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Bone Level Octa Abutment
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref S-BOA10Ref S-ZMOA4310Ref S-ZMOA4320
by Novodent SA
Identity
- Trade Name
- Bone Level Octa Abutment EUDAMEDImplantswiss FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Bone Level Octa Abutment EUDAMEDBonel level Octa Abutment 4.8 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-BOA10 EUDAMEDFDA UDIS-ZMOA4310 EUDAMEDS-ZMOA4320 EUDAMED
- Description
- Bonel level Octa Abutment 4.8 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-BOA10 FDA UDI
- Primary DI / UDI-DI
- 07640168181017 EUDAMEDFDA UDI07630188205985 EUDAMED07630188205992 EUDAMED
- Basic UDI-DI
- B-07640168181017 EUDAMEDB-07630188205985 EUDAMEDB-07630188205992 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 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 Octa 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-07640168181017 | 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 (5)
- EUDAMED b01fd856-9634-4ee4-a727-3b5fc098e965 61 fields · synced Sep 18, 2026
- EUDAMED 47486007-c7c1-4863-a7f4-56c6cf7d3387 61 fields · synced May 18, 2026
- EUDAMED a51486cc-c3b5-4b18-b25a-72923b815b20 61 fields · synced May 18, 2026
- FDA UDI b282ea0b-8478-4ae4-b7b6-d8555bb13dc0 36 fields · synced May 30, 2026
- EUDAMED fd9e0431-ecde-48cf-89bd-7dcf7fb7f9ee 61 fields · synced Jul 8, 2026