Identity
- Trade Name
- Closure Screw EUDAMEDBiodenta FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- CS-B0018B2C EUDAMEDClosure Screw / B2 / H 0.5 / blue / BL & TP FDA UDI
- Model / Reference
- CS-B0018B2C EUDAMEDFDA UDI
- Description
- Closure Screw / B2 / H 0.5 / blue / BL & TP FDA UDI
Identifiers
- Catalog Number
- CS-B0018B2C FDA UDI
- Primary DI / UDI-DI
- 07640169730221 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07640169730221 EUDAMED
- 510(k) Number
- K111003 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
- Czechia EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Closure Screw by Biodenta Swiss AG — 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-07640169730221 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Biodenta Swiss AG
- EUDAMED SRN
- CH-MF-000034374
- Authorised Representative
- MedNet EC-REP IIb GmbH DE-AR-000011192
Sources (2)
- EUDAMED 4095e835-55d7-4c97-9398-8a1cb6a074d6 61 fields · synced Oct 6, 2026
- FDA UDI 72069dca-853a-4880-81a0-4c4f5668ba2e 35 fields · synced May 30, 2026