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Orthodontic Anchor Screw
EUDAMEDClass IIb (EU MDR)
Ref OAS-T1509S-001Model S TypeRef SPL-1507D-001Model D TypeRef CaplantHP-001Model Caplant TypeRef Orthoplant2007T-001Model Special TypeRef Orthoplant-UH-6-001Ref SMS-6-001Ref Orthoplant-UH-9-001Ref Mplant-U3-09-001Ref SL-U3-09-001Ref OAS-T1207T-001Model CT TypeRef Orthoplant2505T-001Ref SL-U3-11-001Ref SL-L1-001Ref SPL-1506-001Model T TypeRef Mplant-U3-07-001Ref SPL-1508D-001Ref OAS-T1508T-001Ref SPL-1509-001Ref Caplant07CCW-001Ref Mplant-U3-11-001Ref OAS-T1208T-001Ref SPL-1511D-001Ref OAS-T1208-LN-001Model C TypeRef OAS-T1506T-001Ref OAS-T1375-LN-001Ref OAS-T1507H-001Model H TypeRef OAS-T1509-LN-001Ref OAS-T1365-001Ref Caplant05CW-001Ref Orthoplant2204H-001Ref OAS-T1506T-LN-001Ref OAS-T1507T-001Ref OAS-T1511-LN-001Ref SMS-5-001Ref Orthoplant2204T-001Ref OAS-T1808-001Ref SPL-1508-001Ref SL-L2-001Ref SPL-1509D-001Ref OAS-T1517-001
Identity
- Trade Name
- Orthodontic Anchor Screw EUDAMED
- Device Name
- OAS-T1509S EUDAMEDSPL-1507D EUDAMEDCaplantHP EUDAMEDOrthoplant2007T EUDAMEDOrthoplant-UH-6 EUDAMEDSMS-6 EUDAMEDOrthoplant-UH-9 EUDAMEDMplant-U3-09 EUDAMEDSL-U3-09 EUDAMEDOAS-T1207T EUDAMEDOrthoplant2505T EUDAMEDSL-U3-11 EUDAMEDSL-L1 EUDAMEDSPL-1506 EUDAMEDMplant-U3-07 EUDAMEDSPL-1508D EUDAMEDOAS-T1508T EUDAMEDSPL-1509 EUDAMEDCaplant07CCW EUDAMEDMplant-U3-11 EUDAMEDOAS-T1208T EUDAMEDSPL-1511D EUDAMEDOAS-T1208-LN EUDAMEDOAS-T1506T EUDAMEDOAS-T1375-LN EUDAMEDOAS-T1507H EUDAMEDOAS-T1509-LN EUDAMEDOAS-T1365 EUDAMEDCaplant05CW EUDAMEDOrthoplant2204H EUDAMEDOAS-T1506T-LN EUDAMEDOAS-T1507T EUDAMEDOAS-T1511-LN EUDAMEDSMS-5 EUDAMEDOrthoplant2204T EUDAMEDOAS-T1808 EUDAMEDSPL-1508 EUDAMEDSL-L2 EUDAMEDSPL-1509D EUDAMEDOAS-T1517 EUDAMED
- Model / Reference
- S Type EUDAMEDOAS-T1509S-001 EUDAMEDD Type EUDAMEDSPL-1507D-001 EUDAMEDCaplant Type EUDAMEDCaplantHP-001 EUDAMEDSpecial Type EUDAMEDOrthoplant2007T-001 EUDAMEDOrthoplant-UH-6-001 EUDAMEDSMS-6-001 EUDAMEDOrthoplant-UH-9-001 EUDAMEDMplant-U3-09-001 EUDAMEDSL-U3-09-001 EUDAMEDCT Type EUDAMEDOAS-T1207T-001 EUDAMEDOrthoplant2505T-001 EUDAMEDSL-U3-11-001 EUDAMEDSL-L1-001 EUDAMEDT Type EUDAMEDSPL-1506-001 EUDAMEDMplant-U3-07-001 EUDAMEDSPL-1508D-001 EUDAMEDOAS-T1508T-001 EUDAMEDSPL-1509-001 EUDAMEDCaplant07CCW-001 EUDAMEDMplant-U3-11-001 EUDAMEDOAS-T1208T-001 EUDAMEDSPL-1511D-001 EUDAMEDC Type EUDAMEDOAS-T1208-LN-001 EUDAMEDOAS-T1506T-001 EUDAMEDOAS-T1375-LN-001 EUDAMEDH Type EUDAMEDOAS-T1507H-001 EUDAMEDOAS-T1509-LN-001 EUDAMEDOAS-T1365-001 EUDAMEDCaplant05CW-001 EUDAMEDOrthoplant2204H-001 EUDAMEDOAS-T1506T-LN-001 EUDAMEDOAS-T1507T-001 EUDAMEDOAS-T1511-LN-001 EUDAMEDSMS-5-001 EUDAMEDOrthoplant2204T-001 EUDAMEDOAS-T1808-001 EUDAMEDSPL-1508-001 EUDAMEDSL-L2-001 EUDAMEDSPL-1509D-001 EUDAMEDOAS-T1517-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809744967806 EUDAMED08809744969503 EUDAMED08809744968308 EUDAMED08809744964201 EUDAMED08809744964706 EUDAMED08809744967103 EUDAMED08809744964805 EUDAMED08809744966205 EUDAMED08809744965505 EUDAMED08809744962405 EUDAMED08809744964409 EUDAMED08809744965604 EUDAMED08809744965703 EUDAMED08809744968407 EUDAMED08809744966106 EUDAMED08809744969602 EUDAMED08809744962801 EUDAMED08809744968704 EUDAMED08809744968209 EUDAMED08809744966304 EUDAMED08809744962504 EUDAMED08809744969800 EUDAMED08809744961705 EUDAMED08809744962603 EUDAMED08809744962306 EUDAMED08809744967400 EUDAMED08809744962009 EUDAMED08809744960807 EUDAMED08809744968001 EUDAMED08809744963808 EUDAMED08809744963006 EUDAMED08809744962702 EUDAMED08809744962108 EUDAMED08809744967004 EUDAMED08809744964300 EUDAMED08809744961002 EUDAMED08809744968605 EUDAMED08809744965802 EUDAMED08809744969701 EUDAMED08809744960708 EUDAMED
- Basic UDI-DI
- B-08809744967806 EUDAMEDB-08809744969503 EUDAMEDB-08809744968308 EUDAMEDB-08809744964201 EUDAMEDB-08809744964706 EUDAMEDB-08809744967103 EUDAMEDB-08809744964805 EUDAMEDB-08809744966205 EUDAMEDB-08809744965505 EUDAMEDB-08809744962405 EUDAMEDB-08809744964409 EUDAMEDB-08809744965604 EUDAMEDB-08809744965703 EUDAMEDB-08809744968407 EUDAMEDB-08809744966106 EUDAMEDB-08809744969602 EUDAMEDB-08809744962801 EUDAMEDB-08809744968704 EUDAMEDB-08809744968209 EUDAMEDB-08809744966304 EUDAMEDB-08809744962504 EUDAMEDB-08809744969800 EUDAMEDB-08809744961705 EUDAMEDB-08809744962603 EUDAMEDB-08809744962306 EUDAMEDB-08809744967400 EUDAMEDB-08809744962009 EUDAMEDB-08809744960807 EUDAMEDB-08809744968001 EUDAMEDB-08809744963808 EUDAMEDB-08809744963006 EUDAMEDB-08809744962702 EUDAMEDB-08809744962108 EUDAMEDB-08809744967004 EUDAMEDB-08809744964300 EUDAMEDB-08809744961002 EUDAMEDB-08809744968605 EUDAMEDB-08809744965802 EUDAMEDB-08809744969701 EUDAMEDB-08809744960708 EUDAMED
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass IIa EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Orthodontic Anchor Screw by BioMaterials Korea, Inc. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08809744967806 | Class IIb | Active |
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Manufacturer
- Manufacturer
- BioMaterials Korea, Inc.
- EUDAMED SRN
- KR-MF-000019882
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (40)
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