UniFit Implant Analog
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Identity
- Trade Name
- UniFit Implant Analog EUDAMEDFDA UDI
- Generic Name
- Dental implant analog FDA UDI
- Model / Reference
- Analog EUDAMEDUF0007 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290109307817 EUDAMEDFDA UDI
- Basic UDI-DI
- 729010930ImplantianalgBQ EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010207 DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY EUDAMED
- GMDN Term
- Dental implant analog FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Dental implant suprastructure, temporary, preformed, single-use
UniFit Implant Analog by Adin Dental Implant Systems Ltd. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K223714 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 729010930ImplantianalgBQ | Class I | Active |
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Manufacturer
- Manufacturer
- Adin Dental Implant Systems LTD.
- EUDAMED SRN
- IL-MF-000014625
- FDA Applicant
- Adin Dental Implant Systems , Ltd.
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (3)
- EUDAMED 19a5cca9-4b63-4951-8e5f-9542f7e7f6e9 85 fields · synced Jun 18, 2026
- FDA UDI b76efb1b-450b-41d9-a3ec-bde572bf9cb5 32 fields · synced May 30, 2026
- FDA 510(k) K223714 1 fields · synced May 18, 2026