← Back to catalogue
Octa Abutment Healing Cap
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref S-OAHCapRef S-MUTCapS
by Novodent SA
Identity
- Trade Name
- Octa Abutment Healing Cap EUDAMEDImplantswiss FDA UDI
- Generic Name
- Dental implant suprastructure kit FDA UDI
- Device Name
- Octa Abutment Healing Cap EUDAMEDOcta Abutment Healing Cap Implant system for the support of dental prostheses, aimed at restoring missing teeth for aesthetical and functional purposes. Instruments dedicated to implant system for the support of dental prostheses. FDA UDI
- Model / Reference
- S-OAHCap EUDAMEDFDA UDIS-MUTCapS EUDAMED
- Description
- Octa Abutment Healing Cap Implant system for the support of dental prostheses, aimed at restoring missing teeth for aesthetical and functional purposes. Instruments dedicated to implant system for the support of dental prostheses. FDA UDI
Identifiers
- Catalog Number
- S-OAHCap FDA UDI
- Primary DI / UDI-DI
- 07640168182588 EUDAMEDFDA UDI07630188205350 EUDAMED
- Basic UDI-DI
- B-07640168182588 EUDAMEDB-07630188205350 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Dental implant suprastructure kit FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3980 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
Yes
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
Octa Abutment Healing Cap 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-07640168182588 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Novodent SA
- EUDAMED SRN
- CH-MF-000023309
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 8cf51e99-971e-43f4-9b36-8f10e7098886 61 fields · synced Jul 10, 2026
- EUDAMED e0ba76e7-6da7-4fad-af75-95df9905862c 61 fields · synced May 19, 2026
- FDA UDI 4e7edf5e-f9a7-4d01-b301-2b7feea2f991 34 fields · synced May 30, 2026