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Tissue Level Fixture Hybrid
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref S-TFHR4310
by Novodent SA
Identity
- Trade Name
- Tissue Level Fixture Hybrid EUDAMEDImplantswiss FDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Device Name
- Tissue Level Fixture Hybrid EUDAMEDTissue level Fixture Hybrid SRA 4.3 x 10 mm "Implant system for the support of dental prostheses, aimed at restoring missing teeth for aesthetical and functional purposes. Implant: The part of the system that is inserted in and connected to the jaw bone to allow for prosthesis superstructure fixation, which includes an abutment." FDA UDI
- Model / Reference
- S-TFHR4310 EUDAMEDFDA UDI
- Description
- Tissue level Fixture Hybrid SRA 4.3 x 10 mm "Implant system for the support of dental prostheses, aimed at restoring missing teeth for aesthetical and functional purposes. Implant: The part of the system that is inserted in and connected to the jaw bone to allow for prosthesis superstructure fixation, which includes an abutment." FDA UDI
Identifiers
- Catalog Number
- S-TFHR4310 FDA UDI
- Primary DI / UDI-DI
- 07640168181833 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07640168181833 EUDAMED
- 510(k) Number
- K181266 FDA UDI
- FDA Product Code
- DZE FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
- GMDN Term
- Screw endosteal dental implant, two-piece FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Tissue Level Fixture Hybrid 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-07640168181833 | 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 e979065c-6b16-461b-b503-99b45d5b977c 61 fields · synced Jul 16, 2026
- FDA UDI 1df6e782-deb5-4848-b80d-e10a1886a8dd 36 fields · synced May 30, 2026