Identity
- Trade Name
- Temporary Abutment FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Model / Reference
- ICTANR4091ES FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800023144673 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
Yes
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 Temporary Abutment is a prefabricated dental device designed to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration. It features one or more structural component(s) such as abutments, bars, and rings, made of various materials including titanium, plastic, and gold alloy. The device has a stable and durable design, suitable for extended use.
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 516546b2-1d47-4e1a-a6b5-3872b374cacd 34 fields · synced Aug 4, 2026