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Bone Level Angled Abutment
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref S-BMUA48293Ref S-ZAA43205Ref S-ZMUA43172Ref S-ZMUA431705Ref S-BAA65254Ref S-BMUA48352Ref S-ZMUA43174
by Novodent SA
Identity
- Trade Name
- Bone Level Angled Abutment EUDAMEDImplantswiss FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Bone Level Angled Abutment EUDAMEDBone level Angled Abutment 6.5 x 25 x 4(Cuff) 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-BMUA48293 EUDAMEDS-ZAA43205 EUDAMEDS-ZMUA43172 EUDAMEDS-ZMUA431705 EUDAMEDS-BAA65254 EUDAMEDFDA UDIS-BMUA48352 EUDAMEDS-ZMUA43174 EUDAMED
- Description
- Bone level Angled Abutment 6.5 x 25 x 4(Cuff) 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-BAA65254 FDA UDI
- Primary DI / UDI-DI
- 07630188205916 EUDAMED07630188205930 EUDAMED07630188201307 EUDAMED07630188201284 EUDAMED07640168180744 EUDAMEDFDA UDI07640168184469 EUDAMED07630188205947 EUDAMED
- Basic UDI-DI
- B-07630188205916 EUDAMEDB-07630188205930 EUDAMEDB-07630188201307 EUDAMEDB-07630188201284 EUDAMEDB-07640168180744 EUDAMEDB-07640168184469 EUDAMEDB-07630188205947 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 EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA 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 Angled 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-07630188205916 | 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 (8)
- EUDAMED fecfbe8b-8bdc-47f7-a47d-9aecbba962ea 61 fields · synced Jul 30, 2026
- EUDAMED 2312846a-63ef-4612-86ba-0073a4245906 61 fields · synced May 17, 2026
- EUDAMED fa9fc99c-df5a-4b09-bd41-e148177ee9ff 61 fields · synced May 17, 2026
- EUDAMED 65cf40f5-7e14-4042-b707-7011819d9e2c 61 fields · synced May 18, 2026
- EUDAMED c8c01294-3142-41ee-b8ac-20301e0687de 61 fields · synced May 18, 2026
- EUDAMED 873f5792-a482-4eff-9aab-3e9495e676b8 61 fields · synced May 18, 2026
- EUDAMED 8fe43ba6-ce6a-4103-862c-58d256ca66c8 61 fields · synced May 18, 2026
- FDA UDI 92796f82-a875-4e4b-a3fe-54cd9c2eb9f6 35 fields · synced May 30, 2026