Identity
- Trade Name
- Healing Abutment EUDAMEDBiodenta FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- HA-B2040B1H EUDAMEDHealing Abutment / B1 / yellow / D 4.0 / GH 2.0 / BL & TP FDA UDI
- Model / Reference
- HA-B2040B1H EUDAMEDFDA UDI
- Description
- Healing Abutment / B1 / yellow / D 4.0 / GH 2.0 / BL & TP FDA UDI
Identifiers
- Catalog Number
- HA-B2040B1H FDA UDI
- Primary DI / UDI-DI
- 07640169730047 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07640169730047 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
Healing Abutment 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-07640169730047 | 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 a0c21231-30f8-4a6e-82a4-f37dd084bbd5 61 fields · synced Jun 18, 2026
- FDA UDI 74c5433b-e43b-46b7-8d99-32749904a699 35 fields · synced May 30, 2026