Identity
- Trade Name
- Healing Abutment FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Model / Reference
- ICHAR453 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800023151237 FDA UDI
- 510(k) Number
- K210039 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant suprastructure, permanent, preformed 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
Yes
Single Use
Yes
Implantable
Yes
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
Yes
Category: Dental implant suprastructure, permanent, preformed
The Healing Abutment is a prefabricated dental implant device that provides a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration. This abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation.
Similar devices
Also classified as Dental implant suprastructure, permanent, preformed.
- SPARE CAST. SLEEVE FOR — SWEDEN & MARTINA INC · Class II
- HS/HG Prosthetic System — OSSTEM IMPLANT Co., Ltd. · Class II
- DESS dental smart solutions — TERRATS MEDICAL SL. · Class II
- Diamodent — Diamodent · Class II
- Cemented Abutment — POINTIMPLANT Co., Ltd. · Class II
- GS System — OSSTEM IMPLANT Co., Ltd. · Class II
- EZ Post — Megagen Implant Co. Ltd · Class II
- Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A. · Class II
Cleared under the same submission
K210039 also covers:
- Angled Abutment — Cybermed Inc.
- Angled Abutment — Cybermed Inc.
- Angled Abutment — Cybermed Inc.
- Angled Abutment — Cybermed Inc.
- Angled Abutment — Cybermed Inc.
- Angled Abutment — Cybermed Inc.
- Angled Abutment — Cybermed Inc.
- Angled Abutment — Cybermed Inc.
- Angled Abutment — Cybermed Inc.
- Angled Abutment — Cybermed Inc.
- Angled Abutment — Cybermed Inc.
- Angled Abutment — Cybermed Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Cybermed Inc.
Sources (1)
- FDA UDI d9f9fc74-7a9d-490b-a031-d40a8988bbe6 34 fields · synced Jul 19, 2026