Identity
- Trade Name
- UniFit Retaining Screw for TMA 1mm FDA UDI
- Generic Name
- Dental prosthesis/implant abutment screw FDA UDI
- Model / Reference
- UF0039 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290109304991 FDA UDI
- 510(k) Number
- K223714 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental prosthesis/implant abutment screw 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Dental prosthesis/implant abutment screw
UniFit Retaining Screw for TMA 1mm by Adin Dental Implant Systems Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental prosthesis/implant abutment screw.
- Azure — TERRATS MEDICAL SL. · Class II
- Inclusive — PRISMATIK DENTALCRAFT, INC. · Class II
- KLOCKNER — SOADCO, S.L. · Class II
- DYNAMIC ABUTMENT SOLUTIONS — TALLADIUM ESPAÑA SL · Class II
- Implant Prosthetics — PREAT Corporation · Class II
- INNO Submerged Implant System-Cemented Abutment — Cowellmedi Co., Ltd · Class II
- MEDENTiKA — Medentika GmbH · Class II
- Azure — TERRATS MEDICAL SL. · Class II
Cleared under the same submission
K223714 also covers:
- C-Type Ti Base UniFit Abutment, GH 1mm Engaged — ADIN DENTAL IMPLANT SYSTEMS LTD
- C-Type Ti Base UniFit Abutment, GH 1mm Engaged Wide — ADIN DENTAL IMPLANT SYSTEMS LTD
- C-Type Ti Base UniFit Abutment, GH 1mm Non Engaged — ADIN DENTAL IMPLANT SYSTEMS LTD
- C-Type Ti Base UniFit Abutment, GH 4mm Non Engaged Wide — ADIN DENTAL IMPLANT SYSTEMS LTD
- Ti Base UniFit Abutment, RH 4mm GH 1mm Angular — ADIN DENTAL IMPLANT SYSTEMS LTD
- Ti Base UniFit Abutment, RH 4mm GH 1mm Engaged — ADIN DENTAL IMPLANT SYSTEMS LTD
- Ti Base UniFit Abutment, RH 4mm GH 1mm Non-Engaged Wide — ADIN DENTAL IMPLANT SYSTEMS LTD
- Ti Base UniFit Abutment, RH 4mm GH 2mm Engaged — ADIN DENTAL IMPLANT SYSTEMS LTD
- Ti Base UniFit Abutment, RH 4mm GH 2mm Engaged Wide — ADIN DENTAL IMPLANT SYSTEMS LTD
- Ti Base UniFit Abutment, RH 4mm GH 3mm Engaged — ADIN DENTAL IMPLANT SYSTEMS LTD
- Ti Base UniFit Abutment, RH 4mm GH 3mm Engaged Wide — ADIN DENTAL IMPLANT SYSTEMS LTD
- Ti Base UniFit Abutment, RH 4mm GH 3mm Non-Engaged — ADIN DENTAL IMPLANT SYSTEMS LTD
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 |
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Manufacturer
- Manufacturer
- Adin Dental Implant Systems Ltd
Sources (1)
- FDA UDI bc58d676-0a5a-4e8e-b9de-5d7a6b8b9f63 33 fields · synced May 30, 2026