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Bone Level Couple Abutment
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref S-BCA5510
by Novodent SA
Identity
- Trade Name
- Bone Level Couple Abutment EUDAMEDImplantswiss FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Bone Level Couple Abutment EUDAMEDBone level Couple Abutment 5.5 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 UDI
- Model / Reference
- S-BCA5510 EUDAMEDFDA UDI
- Description
- Bone level Couple Abutment 5.5 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 UDI
Identifiers
- Catalog Number
- S-BCA5510 FDA UDI
- Primary DI / UDI-DI
- 07640168180300 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07640168180300 EUDAMED
- 510(k) Number
- K200867 FDA UDI
- 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-07640168180300 | 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 (3)
- EUDAMED eb08d399-26d2-40d0-b848-72dee83a49eb 61 fields · synced Jul 25, 2026
- FDA UDI 40ea8d5f-2d01-4810-b075-69bd0c698c23 35 fields · synced May 30, 2026
- EUDAMED f58bb0f5-c4da-4da2-bbe8-190550e35647 61 fields · synced Jul 25, 2026