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Bone Level Couple Abutment
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref S-BCA5550Ref S-BCAN6540Ref S-BCA5530Ref S-BCA4520Ref S-BCA4510Ref S-BCAN45107Ref S-BCA4540
by Novodent SA
Identity
- Trade Name
- Bone Level Couple Abutment EUDAMEDBone Level Couple Abutment Non-Hex EUDAMEDImplantswiss FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Bone Level Couple Abutment EUDAMEDBone Level Couple Abutment Non-Hex EUDAMEDBone level Couple Abutment 4.5 x 4.0 mm "Implant system for the support of dental prostheses, aimed at restoring missing teeth for aesthetical and functional purposes. Abutment: The part of the system that makes the link between the implant part and the prosthetic super structure." FDA UDIBone level Couple Abutment 4.5 x 1.0 mm "Implant system for the support of dental prostheses, aimed at restoring missing teeth for aesthetical and functional purposes. Abutment: The part of the system that makes the link between the implant part and the prosthetic super structure." FDA UDIBone level Couple Abutment 5.5 x 5.0 mm Implant system for the support of dental prostheses, aimed at restoring missing teeth for aesthetical and functional purposes. Abutment: The part of the system that makes the link between the implant part and the prosthetic super structure. FDA UDIBone level Couple Abutment 5.5 x 3.0 mm Implant system for the support of dental prostheses, aimed at restoring missing teeth for aesthetical and functional purposes. Abutment: The part of the system that makes the link between the implant part and the prosthetic super structure. FDA UDIBone level Couple Abutment Non-Hex 6.5 x 4.0 mm Implant system for the support of dental prostheses, aimed at restoring missing teeth for aesthetical and functional purposes. Abutment: The part of the system that makes the link between the implant part and the prosthetic super structure. FDA UDIBone level Couple Abutment 4.5 x 2.0 mm "Implant system for the support of dental prostheses, aimed at restoring missing teeth for aesthetical and functional purposes. Abutment: The part of the system that makes the link between the implant part and the prosthetic super structure." FDA UDI
- Model / Reference
- S-BCA5550 EUDAMEDFDA UDIS-BCAN6540 EUDAMEDFDA UDIS-BCA5530 EUDAMEDFDA UDIS-BCA4520 EUDAMEDFDA UDIS-BCA4510 EUDAMEDFDA UDIS-BCAN45107 EUDAMEDS-BCA4540 EUDAMEDFDA UDI
- Description
- Bone level Couple Abutment 4.5 x 4.0 mm "Implant system for the support of dental prostheses, aimed at restoring missing teeth for aesthetical and functional purposes. Abutment: The part of the system that makes the link between the implant part and the prosthetic super structure." FDA UDIBone level Couple Abutment 4.5 x 1.0 mm "Implant system for the support of dental prostheses, aimed at restoring missing teeth for aesthetical and functional purposes. Abutment: The part of the system that makes the link between the implant part and the prosthetic super structure." FDA UDIBone level Couple Abutment 5.5 x 5.0 mm Implant system for the support of dental prostheses, aimed at restoring missing teeth for aesthetical and functional purposes. Abutment: The part of the system that makes the link between the implant part and the prosthetic super structure. FDA UDIBone level Couple Abutment 5.5 x 3.0 mm Implant system for the support of dental prostheses, aimed at restoring missing teeth for aesthetical and functional purposes. Abutment: The part of the system that makes the link between the implant part and the prosthetic super structure. FDA UDIBone level Couple Abutment Non-Hex 6.5 x 4.0 mm Implant system for the support of dental prostheses, aimed at restoring missing teeth for aesthetical and functional purposes. Abutment: The part of the system that makes the link between the implant part and the prosthetic super structure. FDA UDIBone level Couple Abutment 4.5 x 2.0 mm "Implant system for the support of dental prostheses, aimed at restoring missing teeth for aesthetical and functional purposes. Abutment: The part of the system that makes the link between the implant part and the prosthetic super structure." FDA UDI
Identifiers
- Catalog Number
- S-BCA4540 FDA UDIS-BCA4510 FDA UDIS-BCA5550 FDA UDIS-BCA5530 FDA UDIS-BCAN6540 FDA UDIS-BCA4520 FDA UDI
- Primary DI / UDI-DI
- 07640168180348 EUDAMEDFDA UDI07640168180584 EUDAMEDFDA UDI07640168180324 EUDAMEDFDA UDI07640168180263 EUDAMEDFDA UDI07640168180256 EUDAMEDFDA UDI07630188201055 EUDAMED07640168180287 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07640168180348 EUDAMEDB-07640168180584 EUDAMEDB-07640168180324 EUDAMEDB-07640168180263 EUDAMEDB-07640168180256 EUDAMEDB-07630188201055 EUDAMEDB-07640168180287 EUDAMED
- FDA Product Code
- NHA FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Market of Registration
- Türkiye EUDAMEDSweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDEUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Bone Level Couple Abutment by Novodent SA — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07640168180348 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Novodent SA
- EUDAMED SRN
- CH-MF-000023309
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (19)
- EUDAMED c6e8febd-ec09-4105-a432-537d400a8f3c 61 fields · synced Jul 24, 2026
- EUDAMED 8bff846d-a2ac-43c4-8792-d193cf1c944d 61 fields · synced May 17, 2026
- EUDAMED b310aa25-3efb-4836-9f8a-ddc5e629c2a0 61 fields · synced May 17, 2026
- EUDAMED 68f342cb-e3e9-450c-8235-0c5413262b31 61 fields · synced May 18, 2026
- EUDAMED 1eb45011-2962-4145-86e8-9c242df033e5 61 fields · synced May 18, 2026
- EUDAMED d15ce43b-9b6b-4624-bb3b-eb51524e725f 61 fields · synced May 18, 2026
- EUDAMED c9fad55e-ac40-4305-a6d1-9df36de1c047 61 fields · synced May 19, 2026
- FDA UDI 583729c3-fe7e-4716-ae8d-7e29a43333b7 36 fields · synced May 29, 2026
- FDA UDI 3e36408d-decd-4b1f-8f2c-dcf2cd328de4 36 fields · synced May 29, 2026
- FDA UDI 8e130985-4594-445c-9d07-dfcfa9a94c80 35 fields · synced May 30, 2026
- FDA UDI 0ce5b912-665d-4f08-81ce-ba6e18e721c0 35 fields · synced May 30, 2026
- FDA UDI 13d0b7ee-fa35-46cb-96e4-9e067113faa7 35 fields · synced May 30, 2026
- FDA UDI 29803643-78d1-4abe-ab4a-488f23685de1 36 fields · synced May 30, 2026
- EUDAMED 8ebd8c61-d454-4c9b-8caa-f4cb4a415803 61 fields · synced Jun 20, 2026
- EUDAMED 3d67a718-6bb6-4d7d-8ec8-a39693300709 61 fields · synced Jul 8, 2026
- EUDAMED 8c46cf19-9e36-4812-8350-48ae14e96689 61 fields · synced Jul 9, 2026
- EUDAMED a3ac7499-610a-4beb-9355-b0022ac994ce 61 fields · synced Jul 19, 2026
- EUDAMED d1c0a20a-52ed-495d-b641-12ed7ac92997 61 fields · synced Jul 22, 2026
- EUDAMED d8831411-0138-4997-b353-adb735de990f 61 fields · synced Jul 24, 2026