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Bone Level O-Ring Abutment
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref S-BORA10
by Novodent SA
Identity
- Trade Name
- Bone Level O-Ring Abutment EUDAMEDImplantswiss FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Bone Level O-Ring Abutment EUDAMEDBone level O-Ring Abutment 3.42 x 1.0(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-BORA10 EUDAMEDFDA UDI
- Description
- Bone level O-Ring Abutment 3.42 x 1.0(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-BORA10 FDA UDI
- Primary DI / UDI-DI
- 07640168184353 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07640168184353 EUDAMED
- 510(k) Number
- K181266 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 O-Ring 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-07640168184353 | 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 (2)
- EUDAMED 2ca28657-273e-4093-99c5-fc2a3ca8cf1a 61 fields · synced Jun 18, 2026
- FDA UDI a68c5f22-c1d8-4929-b0cd-16cd268f2af3 35 fields · synced May 30, 2026