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Tissue Level Healing Abutment Wide
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref S-THAW35Ref S-THAW55
by Novodent SA
Identity
- Trade Name
- Tissue Level Healing Abutment Wide EUDAMEDImplantswiss FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- Tissue Level Healing Abutment Wide EUDAMEDTissue level Healing Abutment Wide 6.4 x 5.5 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-THAW35 EUDAMEDS-THAW55 EUDAMEDFDA UDI
- Description
- Tissue level Healing Abutment Wide 6.4 x 5.5 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-THAW55 FDA UDI
- Primary DI / UDI-DI
- 07630188203226 EUDAMED07640168182335 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07630188203226 EUDAMEDB-07640168182335 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, temporary, preformed, single-use 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
Tissue Level Healing Abutment Wide 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-07630188203226 | 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 a1d327eb-643d-4818-82e7-83782dc6091f 61 fields · synced Aug 4, 2026
- EUDAMED 31b97819-84fd-44ed-b66c-0537daaeb5ac 61 fields · synced May 16, 2026
- FDA UDI 178c6ebc-1e33-4489-93c6-b8b28430cd9f 35 fields · synced May 30, 2026