Identity
- Trade Name
- Biodenta FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- Healing Abutment / B0 / green / D 4.0 / GH 6.0 / BL & TP FDA UDI
- Model / Reference
- HA-B6040B0H FDA UDI
- Description
- Healing Abutment / B0 / green / D 4.0 / GH 6.0 / BL & TP FDA UDI
Identifiers
- Catalog Number
- HA-B6040B0H FDA UDI
- Primary DI / UDI-DI
- 07640169730030 FDA UDI
- 510(k) Number
- K123512 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Dental implant suprastructure, temporary, preformed, single-use
Biodenta by Biodenta Swiss AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, temporary, preformed, single-use.
- Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
- Retaining Screw for Digital Model Analog — ADIN DENTAL IMPLANT SYSTEMS LTD. · Class I
- Falcon — Falcon Surgical Co. (Pvt.) Ltd · Class I
- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Neoss Implant System — Neoss, Ltd. · Class II
- Scanbody Screw — ARUM DENTISTRY Co., Ltd. · Class I
Cleared under the same submission
K123512 also covers:
- Biodenta — Biodenta Swiss AG
- Biodenta — Biodenta Swiss AG
- Biodenta — Biodenta Swiss AG
- Biodenta — Biodenta Swiss AG
- Biodenta — Biodenta Swiss AG
- Biodenta — Biodenta Swiss AG
- Biodenta — Biodenta Swiss AG
- Biodenta — Biodenta Swiss AG
- Biodenta — Biodenta Swiss AG
- Biodenta — Biodenta Swiss AG
- Biodenta — Biodenta Swiss AG
- Biodenta — Biodenta Swiss AG
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biodenta Swiss AG
Sources (1)
- FDA UDI 13f5b4c2-28e8-4c9c-9164-0cf31d4d0d42 35 fields · synced May 29, 2026