Identity
- Trade Name
- UniFit Non-Engaging Temporary Abutment 4.5mmD FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Model / Reference
- UF0044 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290109303727 FDA UDI
- 510(k) Number
- K223714 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Dental implant suprastructure, temporary, preformed, single-use
UniFit Non-Engaging Temporary Abutment 4.5mmD by Adin Dental Implant Systems Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, temporary, preformed, single-use.
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- 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
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 e5fd1ec1-f9a7-4037-be2f-ffce9b3c98f4 33 fields · synced Jun 8, 2026