Bafani ba Li-bracket ba 10 ba Tiisitsoeng ka ho Fetisisa ba CE-Certified Bracket Europe (2025 E ntlafalitsoe)

Ho khetha morekisi ea nepahetseng oa bracket bracket ho bohlokoa bakeng sa litloaelo tsa orthodontic Europe. Setifikeiti sa CE se tiisa ho latela melaoana e thata ea EU, ho netefatsa polokeho le boleng ba sehlahisoa.Merero ea taolo joalo ka EU MDR e hloka hore bahlahisi ba ntlafatse litsamaiso tsa taolo ea bolengle ho ntlafatsa mekhoa ea tlhahlobo ea lihlahisoa. Mehato ena e netefatsa hore barekisi ba orthodontic EU ba fihlella litekanyetso tse phahameng, ho sireletsa litholoana tsa mokuli. Ho se ikamahanye le molao ho beha kotsi ea tahlehelo ea lichelete le kotsi ea botumo, ho etsa hore ho latela melao ho be bohlokoa. Ntlafatso ena ea 2025 e totobatsa barekisi ba ipabolang ka boleng, boqapi le khotsofalo ea bareki, ba fanang ka tharollo e tšepahalang bakeng sa litsebi tsa orthodontic.

Lintlha tsa bohlokoa

• Setifikeiti sa CE se bonts'a li-braces li kopana le melao ea polokeho le boleng ba EU.
• Ho khetha barekisi ka lihlahisoa tse ngata ho thusa ho fihlela litlhoko tse fapaneng tsa bakuli.
• Maikutlo a matle a morekisi a haha ​​tšepo le ho ama khetho ea ho reka.
• Bafepedi ba nang le tshehetso ba nolofatsa mosebetsi mme ba thehe tshepo.
• Theknoloji e ncha, joalo ka khatiso ea 3Dle AI, e etsa hore liphekolo li be betere.
• Licheke tsa kamehla le ISO 13485: 2016 li boloka litsamaiso tsa boleng li le matla.
• Ho hlahloba hore na barekisi ba sebetsana le mathata joang ho netefatsa litšebeletso tse ntle le litokiso.
• Ho sebetsa le barekisi ba tšepahalang ho fana ka boleng bo tsitsitseng le tlhokomelo e betere.

Mekhoa ea ho Khetha Bafani ba Kaholimo ba Orthodontic EU

Setifikeiti sa CE le Tumellano

Setifikeiti sa CE se bapala karolo ea bohlokoa ho netefatsa polokeho le boleng ba lihlahisoa tsa orthodontic Europe. Bafani ba thepa ba tlameha ho khomarela litekanyetso tse thata tsa taolo, joalo ka EU Medical Device Regulation (EU MDR), e laelang litlhahlobo tsa bongaka, taolo ea likotsi, le tlhahlobo ea kamora 'maraka.ISO 13485:2016 e matlafatsa ho latela melaoka ho theha mekhoa ea tsamaiso ea boleng e etselitsoeng lisebelisoa tsa bongaka.

Lihlahisoa tsa Orthodontic, e hlophisitsoeng e le lisebelisoa tsa bongaka tsa Sehlopha sa IIa, li hloka phatlalatso ea tumellano e tšehetsoeng ke litlhahlobo tse tsoang mekhatlong e tsebisitsoeng. Ts'ebetso ena e leka-lekanya boqapi le polokeho ea mokuli.Letšoao la CE ha le tiise feela ts'ireletso ea EU, bophelo bo botle, le maemo a tikoloho empa hape e matlafatsa tšepo ea bareki. E fokotsa likotsi tsa melato bakeng sa bahlahisi, e ba sireletsa ho tse ka bang teng tse amanang le polokeho ea sehlahisoa.

Boleng ba Sehlahiswa le Range

Mefuta e fapaneng le boleng ba lihlahisoa tse fanoang ke barekisi ba orthodontic EU li ama khetho ea bona haholo. Bafani ba thepa ba ka sehloohong ba sebelisa liprothokholo tse matla tsa tlhahlobo ho tseba mefokolo kapele, ho netefatsa ts'epo le ho sireletsa liphetho tsa mokuli.Ho lumellana le litifikeiti tse kang EU MDR le ISO 13485:2016e netefatsa hore dihlahiswa di fihlella polokeho le maemo a matjhaba a boleng.

Bafani ba thepa ba boetse ba boloka litokomane tse qaqileng tsa mehato ea ho laola boleng, e bontšang boitlamo ba bona ba ho sebetsa hantle. Litlhahlobo tsa khafetsa le litlhahlobo li tiisa ho latela melao-motheo e phahameng. Mofuta o pharaletseng oa lihlahisoa, o kopantsoeng le boleng bo tsitsitseng, o lumella litsebi tsa orthodontic ho hlokomela litlhoko tse fapaneng tsa bakuli ka katleho.

Botumo le Maikutlo a Bareki

Setumo sa morekisi se bonts'a ts'epo ea hae le boleng ba litšebeletso. Litlhahlobo tse netefalitsoeng le bopaki bo tsoang ho litsebi tsa orthodontic le bakuli li fana ka lintlha tsa bohlokoa mabapi le ts'ebetso ea sehlahisoa le khotsofalo ea bareki. Lipalo-palo li bontša hore 72% ea bareki ba na le monyetla oa ho reka lik'hamphani tse nang le maikutlo a nepahetseng, athe 70% ea bareki ba tšepahalang ba khothalletsa batho ba bang.

Boiphihlelo ba bareki bo bapala karolo ea bohlokoa ho theheng botumo ba mofani oa thepa. Lik'hamphani tse rarollang litletlebo li boloka 80% ea bareki ba tsona kapele, 'me tse fanang ka liphihlelo tsa botho li bona litekanyetso tse phahameng tsa botšepehi. Barekisi ba nang le litšebeletso tse ntle tsa bareki le lisebelisoa tsa koetliso hangata ba fumana lintlha tse phahameng tsa Net Promoter Scores (NPS), e leng se bontšang bobuelli bo matla ba bareki.

Boqapi le Theknoloji

Boqapi ba theknoloji bo fetotse indasteri ea li-orthodontic, ho nolofalletsa barekisi ho fana ka litharollo tse tsoetseng pele tse ntlafatsang tlhokomelo ea bakuli le ho tsamaisa tšebetso ea bona hantle. Barekisi ba etelletseng pele ba orthodontic EU ba sebelisa mahlale a morao-rao ho ntlafatsa ts'ebetso ea sehlahisoa, ho se etsa le ho nepahala.

• Theknoloji ea khatiso ea 3D e hlahile e le phetoho ea lipapali ho orthodontics. E lumella tlhahiso e potlakileng ea li-aligner le li-brackets tse hlakileng, tse fanang ka ntlafatso e ntlafalitsoeng e lumellanang le litlhoko tsa mokuli ka mong. Mokhoa ona o mocha ha o ntlafatse matšeliso a mokuli feela empa hape o fokotsa nako ea phekolo.
• Mekhoa ea ho hlahloba le ho rera kalafo e tsamaisoang ke AI e fetola tsela eo lingaka tsa meno li atamelang tlhokomelo ea bakuli. Litsamaiso tsena li sekaseka lintlha ho theha merero e nepahetseng ea kalafo, ho netefatsa liphetho tse ntle le ho fokotsa liphoso.
• Lisebelisoa tsa ho hlahloba ka dijithale le lisebelisoa tse bohlale tsa meno li ntse li ntlafatsa boiphihlelo ba mokuli. Lisebelisoa tsena li ntlafatsa ho nepahala nakong ea li-fittings le ho fokotsa tlhokahalo ea liphetoho tsa matsoho, ho etsa hore mekhoa e sebetse hantle le e fokolang.

Sengoliloeng sa Hlakola 2024 se totobatsa karolo ea AI ho ntlafatseng moralo oa kalafo, ha tlaleho ea Pherekhong 2024 e totobatsa boleng ba litšenyehelo tsa khatiso ea 3D ka boqapi bo hlakileng ba aligner. Lintlafatso tsena li totobatsa bohlokoa ba boiqapelo ho boloka maemo a holimo ka har'a indasteri ea orthodontic.

Tšehetso ea Bareki le Tšebeletso ea Ka mor'a Thekiso

Tšehetso e ikhethang ea bareki le tšebeletso ea ka mor'a thekiso ke lintlha tsa bohlokoa tse khethollang barekisi ba phahameng ba orthodontic EU. Likhamphani tse etelletsang pele khotsofalo ea bareki li theha likamano tsa nako e telele le ho ts'epana har'a bareki ba tsona. Mekhoa ea ts'ehetso e sebetsang e netefatsa hore lingaka tsa meno li ka itšetleha ka bafani ba tsona bakeng sa thuso, koetliso le tharollo ea mathata.

Lintlha tsa bohlokoa tsa ts'ebetso li tiisa katleho ea litšebeletso tsa tšehetso ea bareki:

Barekisi ba nang le lintlha tse phahameng tsa CSAT le NPS ba bonts'a boitlamo ba bona mekhoeng e shebaneng le bareki. Ts'ebeletso e sebetsang hantle ka mor'a thekiso, joalo ka ho rarolla bothata ka potlako le lisebelisoa tse fumanehang tsa koetliso, e netefatsa hore lingaka tsa meno li ka tsepamisa maikutlo ho faneng ka tlhokomelo ea boleng ho bakuli ba bona. Ka ho tsetela lits'ebetsong tse matla tsa ts'ehetso, bafani ba thepa ba matlafatsa setumo sa bona le ho khothaletsa bots'epehi ka har'a sechaba sa orthodontic.

Bafepedi ba Borakete ba Bracket ba 10 ba netefalitsoeng ka CE Europe

Mofani oa 1: Lumellanya Theknoloji

Kakaretso ea Khampani

Align Technology, moetapele oa lefats'e oa orthodontics, o sebetsa ka thata ho rarolla mathata a macha bakeng sa litsebi tsa meno. E thehiloe ka 1997, k'hamphani e na le ntlo-kholo ea Tempe, Arizona, e nang le boteng bo matla Europe. Align Technology e tsebahala haholo ka Invisalign system, e fetotseng kalafo ea orthodontic lefatšeng ka bophara. Khamphani e sebetsa linaheng tse fetang 100, e fana ka lihlahisoa tsa maemo a holimo tse etelletsang pele boiketlo ba mokuli le katleho.

Lihlahisoa le Likarolo tsa Bohlokoa

Sehlahisoa se hlahelletseng sa Theknoloji, Invisalign, se na le li-aligner tse hlakileng tse etselitsoeng ho otlolla meno ka masene. Li-aligners tsena li sebelisa lisebelisoa tsa SmartTrack, li netefatsa hore li lekana hantle ebile li le boiketlo. Khamphani e boetse e fana ka iTero intraoral scanner, e ntlafatsang ho nepahala ha kalafo ka maikutlo a nepahetseng a dijithale. Lihlahisoa tsa Theknoloji tsa ho lumellana li hokahane ka mokhoa o se nang moeli le lisebelisoa tsa moralo oa phekolo tse tsamaisoang ke AI, tse nolofalletsang lingaka tsa meno ho fana ka tlhokomelo ea motho ka mong.

Setifikeiti le Boikamahanyo

Align Technology e latela litekanyetso tse thata tsa taolo, ho kenyeletsoa setifikeiti sa CE le ISO 13485:2016. Lisetifikeiti tsena li netefatsa polokeho le boleng ba lihlahisoa tsa eona, li fihlela litlhoko tsa EU Medical Device Regulation (EU MDR). Khampani e etsa liteko tse matla le ho boloka litokomane tse qaqileng ho netefatsa hore e lumellana le litekanyetso tsa machaba.

Lintlha tse Ikhethang tsa ho Rekisa

Align Technology e hlahella ka boitlamo ba eona ba ho ntlafatsa le ho rarolla mathata a mokuli. Sistimi ea eona ea Invisalign e fana ka mofuta o mong o sa bonahaleng ho fapana le litšepe tsa setso, o hohela bakuli ba batlang likhetho tsa botle. Ho kopanngoa ha AI le theknoloji ea ho hlahloba dijithale ho ntlafatsa ho nepahala ha kalafo, ho fokotsa nako ea setulo bakeng sa lingaka tsa meno. Lulahanya phihlello ea lefats'e le marang-rang a ts'ehetso a matla a Theknoloji e tiisa boemo ba eona joalo ka molekane ea tšeptjoang oa litsebi tsa meno.

Mofani oa 2: Ormco

Kakaretso ea Khampani

Ormco, eo e leng pula-maliboho litabeng tsa meno, o 'nile a sebeletsa lingaka tsa meno ka lilemo tse fetang 60. E thehiloe Orange, California, k'hamphani e sebetsa lefatšeng ka bophara, ho kenyelletsa le boteng ba bohlokoa Europe. Ormco e tsepamisitse maikutlo ho nts'etsopele ea lihlahisoa tse ncha tse nolofatsang lits'ebetso tsa orthodontic le ho ntlafatsa liphetho tsa mokuli.

Lihlahisoa le Likarolo tsa Bohlokoa

Sehlahisoa sa Ormco se kenyelletsa Sisteme ea Damon, sistimi e ikemetseng e fokotsang likhohlano le ho matlafatsa boiketlo ba mokuli. Khamphani e boetse e fana ka Insignia, tharollo ea orthodontic ea dijithale e ikhethileng e kopanyang litšoantšo tsa 3D le sebaka se nepahetseng sa bracket. Lihlahisoa tsa Ormco li etselitsoe ho tsamaisa tšebetso le ho fana ka liphetho tse lebelletsoeng esale pele.

Setifikeiti le Boikamahanyo

Ormco e lumellana le litlhoko tsa setifikeiti sa CE le litekanyetso tsa ISO 13485:2016, ho netefatsa polokeho le ts'epahalo ea lihlahisoa tsa eona. Khamphani e latela melaoana e matla ea taolo ea boleng mme e etsa liphuputso khafetsa ho boloka ho latela melaoana ea EU MDR.

Lintlha tse Ikhethang tsa ho Rekisa

Ormco's Damon System e fetola phekolo ea orthodontic ka ho felisa tlhokahalo ea maqhama a elastic, ho fokotsa nako ea phekolo le ho se phutholohe. Sistimi ea Insignia e fana ka mokhoa o hlophisitsoeng ka botlalo, o nolofalletsang lingaka tsa meno ho fihlela liphetho tse nepahetseng tse etselitsoeng mokuli e mong le e mong. Boitelo ba Ormco ho boqapi le tšehetso ea bareki bo e etsa khetho e ratoang har'a barekisi ba orthodontic EU.

Morekisi 3: 3M

Kakaretso ea Khampani

3M, mokhatlo oa machaba oa machaba, o na le botumo ba nako e telele ba bokhabane liindastering tse fapaneng, ho kenyeletsoa le orthodontics. Ntlo-khōlō ea St. Paul, Minnesota, 3M e sebeletsa bareki lefatšeng ka bophara ka ho tsepamisa maikutlo ho matla lipatlisisong le nts'etsopele. Karolo ea k'hamphani ea orthodontic e fana ka lihlahisoa tse fapaneng tse etselitsoeng ho ntlafatsa katleho ea kalafo le khotsofalo ea mokuli.

Lihlahisoa le Likarolo tsa Bohlokoa

3M's Clarity Advanced Ceramic Brackets e kopanya aesthetics le nako e telele, e fana ka khetho e masene bakeng sa bakuli. Khamphani e boetse e fana ka Unitek Gemini SL Self-Ligating Brackets, e fokotsang likhohlano le ho ntlafatsa katleho ea kalafo. Ho feta moo, 3M's APC Flash-Free Adhesive System e nolofatsa bonding, e boloka nako bakeng sa lingaka tsa meno.

Setifikeiti le Boikamahanyo

Lihlahisoa tsa 3M tsa orthodontic li fihlella litekanyetso tsa setifikeiti sa CE mme li latela litlhoko tsa ISO 13485:2016. Khamphani e etsa liteko tse batsi le lits'ebetso tsa netefatso ea boleng ho netefatsa hore lihlahisoa tsa eona li lumellana le melaoana ea EU MDR.

Lintlha tse Ikhethang tsa ho Rekisa

3M e ipabola ka ho kopanya boiqapelo le ts'ebetso. Li-Brackets tsa eona tsa Clarity Advanced Ceramic li fana ka motsoako oa botle le ts'ebetso, tse ipiletsang ho bakuli ba batlang mekhoa ea phekolo e masene. APC Flash-Free Adhesive System e ntlafatsa ts'ebetso ea ts'ebetso, e lumella lingaka tsa meno ho tsepamisa maikutlo tlhokomelong ea bakuli. Boitlamo ba 3M ba boleng le boqapi bo tiisa boemo ba bona ba ho ba moetapele indastering ea thuto ea methapo.

Mofani oa 4: American Orthodontics

Kakaretso ea Khampani

American Orthodontics, e thehiloeng ka 1968, ke e 'ngoe ea baetsi ba li-orthodontic ba kholo ka ho fetisisa lefatšeng ka bophara. E thehiloe ho Sheboygan, Wisconsin, k'hamphani e na le boteng ba lefats'e, ho kenyelletsa le sebaka se matla sa Europe. E shebane le ho fana ka lihlahisoa tsa boleng bo holimo tsa orthodontic tse fihlelang litlhoko tsa litsebi tsa meno le bakuli ka ho tšoanang.

Lihlahisoa le Likarolo tsa Bohlokoa

American Orthodontics e fana ka mefuta e mengata ea lihlahisoa, ho kenyeletsa masaka, lithapo le lilasitiki. Li-Brackets tsa eona tsa Empower® ke khetho e tsebahalang, e nang le moralo o ikemetseng o fokotsang likhohlano le ho matlafatsa boiketlo ba mokuli. Khamphani e boetse e fana ka Radiance Plus® Ceramic Brackets, e tsejoang ka boipiletso ba eona bo botle le ho tšoarella nako e telele. Ntle le moo, NiTi Archwires e netefatsa ts'ebeliso e tsitsitseng ea matla, e ntlafatsa ts'ebetso ea kalafo.

Setifikeiti le Boikamahanyo

Khamphani e latela litekanyetso tse thata tsa taolo, ho kenyeletsoa setifikeiti sa CE le ISO 13485: ho latela melao ea 2016. Lisetifikeiti tsena li tiisa hore lihlahisoa tsa eona li fihlela litlhoko tsa polokeho le boleng tse boletsoeng ke EU Medical Device Regulation (EU MDR). American Orthodontics e etsa tlhahlobo ea khafetsa le liteko tse matla ho boloka litekanyetso tsena tse phahameng.

Lintlha tse Ikhethang tsa ho Rekisa

American Orthodontics e hlahella ka boitlamo ba eona ba ho ntlafatsa le ho khotsofatsa bareki. Li-Brackets tsa eona tsa Empower® li nolofatsa ts'ebetso ea orthodontic, li fokotsa nako ea setulo bakeng sa lingaka. Radiance Plus® Ceramic Brackets e fana ka khetho e masene bakeng sa bakuli ba batlang tharollo ea botle. Boinehelo ba k'hamphani ho boleng le mefuta e mengata ea lihlahisoa tsa eona li etsa hore e be molekane ea tšeptjoang bakeng sa litsebi tsa orthodontic lefatšeng ka bophara.

Mofani oa 5: Bongaka ba Denrotary

Kakaretso ea Khampani

Denrotary Medical, e thehiloeng ka 2012, ke mofani ea ka sehloohong oa lihlahisoa tsa orthodontic. E thehiloe Ningbo, Zhejiang, Chaena, k'hamphani e iketselitse botumo ba boleng le ho tšepahala. E sebelisana 'moho le likhoebo lefatšeng ka bophara, ho kenyeletsoa le tse Europe, ho fana ka litharollo tse ncha bakeng sa tlhokomelo ea meno.

Lihlahisoa le Likarolo tsa Bohlokoa

Denrotary Medical e sebetsa ka thata ka masakaneng a orthodontic, lithapo le lisebelisoa. Mehala ea eona e tsoetseng pele ea tlhahiso e etsa li-brackets tse ka bang 10,000 beke le beke, ho netefatsa hore ho na le phepelo e tsitsitseng. Khampani e sebelisa lisebelisoa tsa morao-rao tsa Jeremane ho hlahisa lihlahisoa tsa boleng bo phahameng. Li-brackets tsa eona li etselitsoe ho nepahala le ho tšoarella, ho fihlela litlhoko tse fapaneng tsa litloaelo tsa orthodontic.

Setifikeiti le Boikamahanyo

Denrotary Medical e lumellana le setifikeiti sa CE le litekanyetso tsa ISO 13485:2016. Thupelo ea eona ea morao-rao le mohala oa tlhahiso li latela melao ea bongaka, ho netefatsa polokeho ea sehlahisoa le ho ts'epahala. Boitlamo ba k'hamphani ho boleng bo bonahala liprothokholeng tsa eona tsa liteko tse matla le ho latela maemo a machaba.

Lintlha tse Ikhethang tsa ho Rekisa

Denrotary Medical e ipabola ka ho kopanya theknoloji e tsoetseng pele le tlhahiso e sebetsang hantle. Bokhoni ba eona ba ho hlahisa lihlahisoa tse phahameng bo netefatsa hore lihlahisoa li fanoa ka nako. Tsepamiso ea k'hamphani holim'a boleng le boqapi e etsa hore e be khetho e tšepahalang bakeng sa barekisi ba orthodontic EU. Boinehelo ba eona ho khotsofalo ea bareki bo matlafatsa boemo ba eona 'marakeng.

Mofani oa 6: DENTAURUM GmbH & Co.KG

Kakaretso ea Khampani

DENTAURUM GmbH & Co.KG, e thehiloeng ka 1886, ke k'hamphani ea Jeremane e nang le histori e telele ea bokhabane litabeng tsa orthodontics. Ntlo-khōlō ea eona e Ispringen, Jeremane, ke e 'ngoe ea lik'hamphani tsa meno tsa khale ka ho fetisisa tsa malapa lefatšeng. Khampani e tumme ka lihlahisoa tsa eona tsa boleng bo holimo le boitlamo ba ho ntlafatsa.

Lihlahisoa le Likarolo tsa Bohlokoa

DENTAURUM e fana ka mefuta e fapaneng ea lihlahisoa tsa orthodontic, ho kenyeletsoa masakaneng, lithapo, le li-retainers. Discovery® Smart Brackets ea eona e nkoa e le ea bohlokoa haholo bakeng sa ho nepahala le ho sebelisoa habonolo ha bona. Khamphani e boetse e fana ka lithapo tsa titanium, tse fanang ka maemo a bonolo le matla. Ho feta moo, sistimi ea eona ea Retention Plus® e netefatsa katleho ea kalafo ea nako e telele.

Setifikeiti le Boikamahanyo

DENTAURUM e lumellana le setifikeiti sa CE le ISO 13485: litekanyetso tsa 2016. Lihlahisoa tsa eona li finyella litlhoko tse thata tsa EU MDR, ho netefatsa polokeho le botšepehi. Sistimi ea taolo ea boleng ea k'hamphani e kenyelletsa tlhahlobo ea khafetsa ea lichelete le liteko tse felletseng ho boloka ho latela melao.

Lintlha tse Ikhethang tsa ho Rekisa

Tsebo ea nako e telele ea DENTAURUM le boitlamo ba boleng bo e khetholla. Discovery® Smart Brackets ea eona e nolofatsa lits'ebetso tsa orthodontic, e ntlafatsa ts'ebetso ea lingaka. Tsepamiso ea k'hamphani ho popontšuoa le photefolio ea eona e pharalletseng ea lihlahisoa li e etsa khetho e ratoang har'a barekisi ba orthodontic EU. Boinehelo ba eona ho ts'ebetsong le mekhoa ea boitšoaro bo eketsa botumo ba eona le ho feta.

Mofani oa 7: EKSEN

Kakaretso ea Khampani

EKSEN, lebitso le hlahelletseng indastering ea orthodontic, e sebetsa ho tsoa Turkey mme e sebeletsa bareki ho pholletsa le Europe. Khampani e iketselitse botumo ba ho fana ka lihlahisoa tsa boleng bo holimo tsa orthodontic tse finyellang litekanyetso tsa machaba. E tsepamisitse maikutlo ho boqapi le ho nepahala, EKSEN e fetohile molekane ea tšepahalang bakeng sa litsebi tsa meno tse batlang litharollo tse tšepahalang.

Lihlahisoa le Likarolo tsa Bohlokoa

EKSEN e fana ka mefuta e fapaneng ea lihlahisoa tsa orthodontic, ho kenyelletsa le masaka, lithapo le lisebelisoa. Li-brackets tsa eona tse itšebetsang li etselitsoe ho fokotsa khohlano, ho matlafatsa boiketlo ba mokuli le katleho ea kalafo. Khamphani e boetse e fana ka li-brackets tsa ceramic tse kopanyang nako e telele le boipiletso ba botle. Ho feta moo, li-archwires tsa EKSEN li netefatsa ts'ebeliso ea matla e tsitsitseng, e kenyang letsoho ho liphetho tse sebetsang tsa kalafo.

Setifikeiti le Boikamahanyo

EKSEN e latela litlhoko tsa setifikeiti sa CE, e netefatsa hore lihlahisoa tsa eona li fihlela litekanyetso tse thata tsa polokeho le boleng ba European Union. Khamphani e boetse e latela ISO 13485:2016, e bonts'a boitlamo ba eona ba ho boloka sistimi e matla ea taolo ea boleng. Litlhahlobo tsa khafetsa le liteko tse matla li tiisa ho ts'epahala ha lihlahisoa tsa eona.

Lintlha tse Ikhethang tsa ho Rekisa

EKSEN e hlahelletse ka boitlamo ba eona ho boqapi le khotsofalo ea bareki. Li-brackets tsa eona tse ikemetseng li nolofatsa mekhoa ea orthodontic, ho fokotsa nako ea setulo bakeng sa lingaka. Li-brackets tsa ceramic li fana ka khetho e masene bakeng sa bakuli, e ba etsang khetho e tsebahalang. Ho tsepamisa maikutlo ha EKSEN holim'a boleng le ho nepahala ho entse hore e be le botumo bo matla har'a barekisi ba orthodontic EU.

Mofani oa 8: Dentsply Sirona Inc.

Kakaretso ea Khampani

Dentsply Sirona Inc., ntlo-kholo e Charlotte, North Carolina, ke moetapele oa lefats'e oa theknoloji ea meno le tharollo. Ka ho ba teng ha bohlokoa Europe, k'hamphani e ntse e le ka pele ho boqapi indastering ea orthodontic. Boitlamo ba Dentsply Sirona ba ho ntšetsa pele tlhokomelo ea meno bo entse hore e be lebitso le tšepahalang har'a litsebi lefatšeng ka bophara.

Lihlahisoa le Likarolo tsa Bohlokoa

Dentsply Sirona e fana ka mefuta e fapaneng ea lihlahisoa tsa orthodontic, ho kenyeletsoa mabakete, li-aligner le tharollo ea dijithale. SureSmile® Aligners ea eona e etselitsoe ho nepahala le boiketlo, ho sebelisoa theknoloji e tsoetseng pele ea litšoantšo tsa 3D. Khamphani e boetse e fana ka Li-Brackets tsa In-Ovation®, tse nang le moralo o ikemetseng bakeng sa ts'ebetso e ntlafetseng. Ntle le moo, tharollo ea ts'ebetso ea dijithale ea Dentsply Sirona e tsamaisa moralo oa kalafo le ho ntlafatsa ho nepahala.

Setifikeiti le Boikamahanyo

Dentsply Sirona e lumellana le setifikeiti sa CE le ISO 13485: litekanyetso tsa 2016, ho netefatsa hore lihlahisoa tsa eona li fihlela litlhoko tse phahameng ka ho fetisisa tsa polokeho le boleng. Khamphani e etsa liteko tse batsi 'me e boloka litokomane tse qaqileng ho ikamahanya le melaoana ea EU MDR (EU MDR).

Lintlha tse Ikhethang tsa ho Rekisa

Dentsply Sirona e ipabola tabeng ea ho kopanya theknoloji le tlhokomelo ea meno. SureSmile® Aligners ea eona e fana ka mokhoa o ikhethileng oa kalafo, e ntlafatsang khotsofalo ea mokuli. Li-Brackets tsa In-Ovation® li nolofatsa mekhoa, li fokotsa nako ea phekolo bakeng sa lingaka. Tsepamiso ea Dentsply Sirona mabapi le boqapi le marang-rang a eona a ts'ehetso e matla e etsa hore e be khetho e ratoang bakeng sa litsebi tsa orthodontic.

Mofani oa 9: Envista Holdings Corporation

Kakaretso ea Khampani

Envista Holdings Corporation, e thehiloeng Brea, California, ke mofani ea ka sehloohong oa lihlahisoa tsa meno le tharollo. Khamphani e sebetsa lefatšeng ka bophara, ka boteng bo matla Europe. Envista's portfolio e kenyelletsa tse ling tsa mabitso a tsebahalang indastering ea orthodontic, e bonts'ang boitlamo ba eona ba boleng le boqapi.

Lihlahisoa le Likarolo tsa Bohlokoa

Envista e fana ka mefuta e mengata ea lihlahisoa tsa orthodontic ka lihlahisoa tsa eona, tse kang Ormco le Nobel Biocare. The Damon ™ System, e leng setsi se ikemetseng, ke e 'ngoe ea lihlahisoa tsa eona tse hlahelletseng, tse tsejoang ka ho fokotsa likhohlano le ho matlafatsa boiketlo ba mokuli. Envista e boetse e fana ka tharollo ea dijithale joalo ka Spark ™ Aligners, e sebelisang theknoloji e tsoetseng pele bakeng sa moralo o nepahetseng oa kalafo.

Setifikeiti le Boikamahanyo

Envista e latela setifikeiti sa CE le litekanyetso tsa ISO 13485:2016, ho netefatsa hore lihlahisoa tsa eona li fihlela litlhoko tse tiileng tsa polokeho le boleng ba 'maraka oa Europe. Khampani e sebelisa mehato e tiileng ea taolo ea boleng 'me e etsa liphuputso khafetsa ho boloka ho latela melao ea EU MDR.

Lintlha tse Ikhethang tsa ho Rekisa

Matla a Envista a ka har'a potefolio ea lihlahisoa tse fapaneng le boitlamo ba ho ntlafatsa. Sisteme ea Damon™ e fetola kalafo ea orthodontic ka ho ntlafatsa ts'ebetso le boiketlo ba mokuli. Spark ™ Aligners e fana ka tharollo ea theknoloji e phahameng bakeng sa kalafo e hlakileng ea aligner, e hohelang bakuli ba batlang likhetho tse bohlale. Boinehelo ba Envista ho boleng le phihlello ea eona ea lefats'e ho etsa hore e be lebitso le tšepahalang har'a barekisi ba orthodontic EU.

Mofani oa 10: 3B Orthodontics

Kakaretso ea Khampani

3B Orthodontics, lebitso le tšeptjoang indastering ea li-orthodontic, e iketsetse e le mofani oa thepa ea ka tšeptjoang oa li-brackets tsa boleng bo phahameng. E thehiloe United States, k'hamphani e ekelitse phihlello ea eona ea ho sebeletsa litsebi tsa meno ho pholletsa le Europe. Ka ho tsepamisitse maikutlo ho nepahetseng le boqapi, 3B Orthodontics e iketselitse botumo ba ho fana ka lihlahisoa tse fihlelang litlhoko tsa mekhoa ea sejoale-joale ea orthodontic. Khampani e totobatsa khotsofalo ea bareki mme e ikitlaelletsa ho fana ka litharollo tse matlafatsang tlhokomelo ea bakuli.

Lihlahisoa le Likarolo tsa Bohlokoa

3B Orthodontics e fana ka mefuta e fapaneng ea lihlahisoa tsa orthodontic tse etselitsoeng ho ntlafatsa sephetho sa kalafo. Sehlahisoa sa eona se kenyelletsa:

• Masakana a Tšepe: Li tsejoa ka ho tšoarella le ho nepahala ha tsona, li-brackets tsena li tiisa hore meno a tsamaisana hantle.
• Li-brackets tsa Ceramic: Li-brackets tsena li fana ka khetho e masene bakeng sa bakuli ba batlang tharollo ea botle.
• Masakana a ho Ikamahanya: E etselitsoe ho fokotsa likhohlano, li-brackets tsena li ntlafatsa boiketlo ba mokuli le ho nolofatsa kalafo.
• Lithapo tsa Orthodontic le lisebelisoa: Lihlahisoa tsena li tlatselletsa masakaneng, li netefatsa ts'ebeliso e tsitsitseng ea matla le kalafo e sebetsang.

Khampani e boetse e kopanya mekhoa e tsoetseng pele ea tlhahiso ea ho hlahisa li-brackets tse nang le likarolo tse boreleli, ho fokotsa ho teneha ho bakuli. Lihlahisoa tsa eona li fana ka litlhoko tse ngata tsa orthodontic, e leng se etsang hore e be khetho e fapaneng bakeng sa litsebi tsa meno.

Setifikeiti le Boikamahanyo

3B Orthodontics e khomarela litekanyetso tse thata tsa taolo ho netefatsa polokeho le boleng ba lihlahisoa tsa eona. Khampani e tšoereSetifikeiti sa CE, e netefatsang ho latela litlhoko tsa polokeho le bophelo bo botle ba European Union. E boetse e kopana le maemo aISO 13485:2016, e shebaneng le mekhoa ea tsamaiso ea boleng ba lisebelisoa tsa bongaka. Liphuputso tsa kamehla le liteko tse matla li tiisa ho tšepahala ha lihlahisoa tsa eona. Ka ho boloka litifikeiti tsena, 3B Orthodontics e bontša boitlamo ba eona ba ho fana ka lihlahisoa tse fihlelang maemo a machaba.

Hlokomela: Setifikeiti sa CE se netefatsa hore lihlahisoa tsa 3B Orthodontics li bolokehile, li sebetsa hantle, 'me li loketse ho sebelisoa mebarakeng ea Europe.

Lintlha tse Ikhethang tsa ho Rekisa

3B Orthodontics e hlahella ka boitelo ba eona ho boqapi le boleng. Li-brackets tsa eona tse ikemetseng li nolofatsa mekhoa ea orthodontic, ho fokotsa nako ea setulo bakeng sa lingaka. Li-brackets tsa ceramic li fana ka tharollo e ntle, e ipiletsang ho bakuli ba khethang mekhoa ea phekolo e masene. Tsepamiso ea k'hamphani mabapi le tlhahiso e nepahetseng e netefatsa hore lihlahisoa tsa eona li fana ka sephetho se ts'oanang. Ho feta moo, 3B Orthodontics e fana ka tšehetso e ntle ea bareki, e thusa lingaka tsa meno ho sebetsana le mathata le ho ntlafatsa tlhokomelo ea bakuli.

Ka ho kopanya theknoloji e tsoetseng pele le mokhoa oa ho tsepamisa maikutlo ho bareki, 3B Orthodontics e fumane sebaka sa eona e le mofani oa thepa ea tšepahalang indastering ea orthodontic. Boitlamo ba eona ba boleng le boqapi bo etsa hore e be molekane oa bohlokoa bakeng sa litsebi tsa masapo a Europe.

Mokhoa oa ho Khetha Bafani ba Orthodontic ba Nepahetseng EU bakeng sa Litlhoko tsa Hao

Ho Lekola Litlhoko Tsa Hao

Ho utloisisa litlhoko tse ikhethileng tsa boikoetliso ba orthodontic ke mohato oa pele oa ho khetha mofani oa thepa ea nepahetseng. Litloaelo li lokela ho lekola metrics ea bohlokoa ho netefatsa hore morekisi o ikamahanya le lipheo tsa bona tsa ts'ebetso.Linako tsa thomello li bapala karolo ea bohlokoaka ho boloka ketane ea phepelo e tsitsitseng le ho qoba litšitiso. Mekhoa e boetse e lokela ho lekola katleho ea kalafo ka ho bapisa nako e hakanyetsoang ea kalafo le liphetho tsa 'nete. Sena se thusa ho tseba hore na lihlahisoa tsa morekisi li kenya letsoho tšebetsong e ntlafalitsoeng.

Ho latela litlhoko tsa bakuli le ho lokisoa ho fana ka lintlha tse eketsehileng. Litefiso tse phahameng tse sa bonts'itsoeng kapa ho lokisoa khafetsa ho ka bonts'a mathata a ts'epahalo ea sehlahisoa kapa khotsofalo ea mokuli. Ka ho sekaseka lintlha tsena, litloaelo li ka tseba hore na linyehelo tsa mofani oa thepa li lumellana le maemo a tsona.

Tsenamatšoao a fana ka moralo o felletsengbakeng sa ho hlahloba ho tshwaneleha ha mofani wa thepa, ho netefatsa hore ditsebi tsa orthodontic li etsa liqeto tse nang le tsebo.

Ho bapisa Linyehelo tsa Lihlahisoa

Papiso e phethahetseng ea likarolo tsa sehlahisoa le mekhoa ea litheko e bohlokoa ha ho hlahlojoa barekisi. Litloaelo li lokela ho sekaseka maano a litheko tsa bahlolisani ho bona likheo le menyetla. Mohlala,ho utloisisa theko ea elasticity ho thusa ho tsebakamoo liphetoho tsa theko li amang tlhokahalo. Temohisiso ena e lumella mekhoa ea ho khetha barekisi ba fanang ka litheko tsa tlholisano ntle le ho senya boleng.

Barekisi ba nang le mefuta e fapaneng ea lihlahisoa hangata ba fana ka phetoho e kholoanyane. Litloaelo li lokela ho shebana le likarolo tse ikhethileng tsa data, joalo ka litheolelo kapa linyehelo tse kopaneng, ho eketsa boleng. Ho sebelisa lisebelisoa tse bohlale tsa litheko ho ka ntlafatsa ho etsa liqeto ka ho fana ka leseli le sebetsang.

Ho feta moo, ho bohlokoa ho lekola boleng ba thepa e sebelisoang lihlahisoa. Li-brackets le lithapo tsa boleng bo holimo li tlatsetsa liphellong tse molemo tsa phekolo le khotsofalo ea mokuli. Mekhoa e lokela ho etelletsa pele barekisi ba fanang ka lihlahisoa tse tšepahalang le tse tšoarellang nako le nako.Ho hlwaya likheo maqheka a litheko tsa bahlolisanie ka boela ea thusa litloaelo ho ntlafatsa mefuta ea tsona ea litheko, ho ntlafatsa boemo ba bona ba mebaraka.

Ho lekola Tšehetso ea Bareki

Tšehetso ea bareki ke ntlha ea bohlokoa khethong ea bafani ba thepa. Litloaelo li lokela ho lekola hore na bafani ba thepa ba arabela joang ka potlako le ka nepo lipotsong kapa ho rarolla mathata.Metrics joalo ka nako ea karabo le palo ea likhangfana ka matšoao a ka lekanyetsoang a boleng ba litšebeletso.

Barekisi ba nang le karabelo e phahameng le litefiso tse tlase tsa likhohlano ba bonts'a boitlamo ba ho khotsofatsa bareki. Mekhoa e boetse e lokela ho nahana ka boteng ba lisebelisoa tsa koetliso le tšehetso ea ka mor'a thekiso. Litšebeletso tsena li netefatsa hore lingaka tsa meno li ka sebetsana le liphephetso ka katleho, ho matlafatsa ts'ebetso e sebetsang ka kakaretso.

Likamano tsa nako e telele le bafani ba thepa ba tšepahalang li khothalletsa ho tšepanale ponaletso. Barekisi ba lulang ba fihlela linako tse behiloeng le ho fana ka lihlahisoa tsa boleng bo holimo ba matlafatsa likamano tsena, ba theha motheo oa kholo e tsitsitseng. Ka ho etelletsa pele tšehetso ea bareki, litloaelo li ka theha litšebelisano tse matla tse ruisang mahlakore ka bobeli molemo.

Ho Nahana ka Litšebelisano tsa Nako e telele

Ho theha likamano tsa nako e telele le barekisi ba meno ho fana ka melemo e mengata bakeng sa mekhoa ea meno. Likamano tsena li fetela ka nģ'ane ho litšebelisano tsa khoebo, tse khothalletsang ho tšepana, ho tšepahala, le kholo ea bobeli. Lingaka tsa Orthodontists tse etelletsang pele litšebelisano tsa nako e telele li atisa ho ba le ts'ebetso e bonolo le liphello tse molemo tsa mokuli.

Melemo ea Litšebelisano tsa Nako e telele

1. Boleng bo tsitsitseng ba Sehlahiswa

   Barekisi ba tšepahalang ba netefatsa boleng bo ts'oanang ho mefuta eohle ea lihlahisoa tsa bona. Lingaka tsa meno li ka tšepa hore masaka, lithapo le lisebelisoa tse ling li finyella litekanyetso tse phahameng, tse fokotsang kotsi ea mathata a phekolo. Ho lumellana ho boetse ho eketsa khotsofalo ea mokuli, kaha lihlahisoa tsa boleng bo phahameng li lebisa liphellong tse molemo.

2. Phatlalatso e Batlang

   Likamano tsa nako e telele li nolofatsa tsamaiso ea phepelo ea thepa. Barekisi ba nang le likamano tse tsitsitseng ba utloisisa litlhoko tse khethehileng tsa bareki ba bona. Ho tloaelana hona ho ba lumella ho lebella litaelo, ho fokotsa tieho, le ho boloka phallo e tsitsitseng ea lisebelisoa tsa bohlokoa.

3. Tšebeliso ea Litšenyehelo

   Barekisi ba bangata ba fana ka litheolelo kapa mananeo a botšepehi ho bareki ba nako e telele. Melemo ena e fokotsa litšenyehelo ka kakaretso, e lumella mekhoa ea ho aba lisebelisoa ka katleho. Litumellano tsa ho reka ka bongata kapa litumellano tse ikhethileng li eketsa ho boloka litšenyehelo.

4. Phihlello ho Boqapi

   Hangata barekisi ba tšepahalang ba fana ka phihlello ea pele ea theknoloji le lihlahisoa tse ncha. Lingaka tsa Orthodontists li ka lula li le ka pele ho mekhoa ea indasteri ka ho sebelisa litharollo tse ncha. Phihlello ena e tiisa hore litloaelo li lula li le tlholisano le ho fana ka tlhokomelo ea maemo ho bakuli ba bona.

Lintlha tsa Bohlokoa Bakeng sa ho Aha Likamano Tse Matla

Malebela a ho Khetha Molekane ea Nepahetseng

Keletso: Lekola rekoto ea morekisi pele u itlama ho sebelisana nako e telele. Batla maikutlo a nepahetseng, bopaki, le lithuto tsa liketsahalo tse totobatsang botšepehi ba bona le tšebeletso ea bareki.

Lingaka tsa Orthodont le tsona li lokela ho lekola bokhoni ba morekisi ba ho lekanya ts'ebetso. Mekhoa e ntseng e hola e hloka balekane ba ka fihlelang litlhoko tse ntseng li eketseha ntle le ho senya boleng. Ho feta moo, barekisi ba fanang ka lisebelisoa tsa koetliso le tšehetso ea tekheniki ba eketsa boleng bo kopanetsoeng.

Litšebelisano tsa nako e telele li ruisa mahlakore ka bobeli. Barekisi ba fumana bareki ba tšepahalang, athe lingaka tsa meno li thabela tšebeletso e tsitsitseng le phihlello ea lihlahisoa tse ncha. Ka ho etelletsa pele tšepo le sepheo se arolelanoang, mekhoa ea meno e ka theha likamano tse tsamaisang katleho lilemong tse tlang.

Barekisi ba kaholimo ba 10 ba netefalitsoeng ba li-bracket ba Europe ba ipabola ka boleng, boqapi le khotsofalo ea bareki. Likhamphani tse kang Align Technology le Ormco li etella pele ka litharollo tsa morao-rao, ha Denrotary Medical le DENTAURUM GmbH li bonts'a bokhoni bo ikhethang ba tlhahiso. Mofani e mong le e mong o etelletsa pele ho latela setifikeiti sa CE le litekanyetso tsa ISO 13485:2016, ho netefatsa polokeho le ts'epo.

Keletso: Lekola litlhoko tsa boikoetliso ba hau, mefuta ea lihlahisoa, le tšehetso ea bafani pele u etsa qeto. Likamano tsa nako e telele le bafani ba thepa ba tšepahalang li ka ntlafatsa katleho le tlhokomelo ea mokuli.

Setifikeiti sa CE se ntse se le bohlokoa bakeng sa ho boloka maemo a holimo ho orthodontics, ho sireletsa litsebi le bakuli.

LBH

Setifikeiti sa CE ke eng, 'me ke hobane'ng ha se le bohlokoa bakeng sa lihlahisoa tsa orthodontic?

Setifikeiti sa CE se netefatsa hore sehlahisoa se kopana le polokeho, bophelo bo botle le maemo a tikoloho a European Union. Bakeng sa lihlahisoa tsa orthodontic, e tiisa ho latela melao e thata, ho netefatsa polokeho ea mokuli le ho tšepahala ha sehlahisoa.

Lingaka tsa orthodont li ka netefatsa joang haeba morekisi a e-na le setifikeiti sa CE?

Lingaka tsa Orthodontists li ka hlahloba litokomane tsa semmuso tsa mofani oa thepa kapa matšoao a sehlahisoa bakeng sa letšoao la CE. Ho feta moo, ba ka kopa litifikeiti tsa ho lumellana le melao kapa ho netefatsa ngoliso ea mofani oa thepa le mekhatlo ea taolo ea EU.

Melemo ea ho khetha li-brackets tse netefalitsoeng ke CE ke efe?

Li-brackets tse netefalitsoeng ke CE li netefatsa lisebelisoa tsa boleng bo holimo, polokeho le ho latela litekanyetso tsa EU. Ba fokotsa likotsi tse amanang le bofokoli ba sehlahisoa mme ba matlafatsa ts'epo ea mokuli kalafong ea orthodontic.

ISO 13485:2016 e amana joang le bafani ba li-orthodontic?

ISO 13485:2016 e theha litekanyetso tsa taolo ea boleng bakeng sa lisebelisoa tsa bongaka. Barekisi ba Orthodontic ba khomarelang tekanyetso ena ba bontša boitlamo ba bona ba ho hlahisa lihlahisoa tse bolokehileng, tse tšepahalang le tsa boleng bo holimo.

Ke karolo efe eo boqapi bo e bapalang ntlafatsong ea sehlahisoa sa orthodontic?

Boqapi bo tsamaisa tsoelo-pele ho orthodontics, joalo ka khatiso ea 3D le moralo oa kalafo o tsamaisoang ke AI. Mahlale ana a ntlafatsa ho nepahala ha sehlahisoa, a fokotsa linako tsa kalafo, 'me a ntlafatsa boiketlo ba mokuli.

Lingaka tsa orthodont li ka hlahloba botumo ba mofani oa thepa joang?

Lingaka tsa Orthodontists li ka hlahloba bopaki ba bareki, litekanyetso, le lithuto tsa linyeoe. Maikutlo a netefalitsoeng ho tsoa ho litsebi tse ling li fana ka leseli mabapi le ho ts'epahala ha morekisi, boleng ba sehlahisoa le litšebeletso tsa bareki.

Hobaneng ha ts'ehetso ea kamora thekiso e le bohlokoa ho bafani ba li-orthodontic?

Ts'ehetso ea ka mor'a thekiso e netefatsa hore lingaka tsa orthodont li fumana thuso ka litaba tsa sehlahisoa, koetliso le tlhokomelo. Tšehetso e tšepahalang e etsa hore motho a tšepahale 'me e thusa mekhoa hore e sebetse hantle.

Ke lintlha life tseo lingaka tsa meno li lokelang ho li ela hloko ha li khetha mofani oa thepa?

Lingaka tsa Orthodontists li lokela ho lekola boleng ba sehlahisoa, litifikeiti, tšehetso ea bareki le boqapi. Likamano tsa nako e telele le bafani ba thepa ba ka tšeptjoang li netefatsa tšebeletso e tsitsitseng le ho fumana litharollo tse tsoetseng pele.

Keletso: Ka linako tsohle beha bafani ba thepa pele ka tlaleho e netefalitsoeng ea ho latela melao le khotsofalo ea bareki.