Identity
- Trade Name
- 3i Certain FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- Biomet 3i Certain®-compatible 3.4mm Non-Engaging Plastic UCLA FDA UDI
- Model / Reference
- 8001615 FDA UDI
- Description
- Biomet 3i Certain®-compatible 3.4mm Non-Engaging Plastic UCLA FDA UDI
Identifiers
- Catalog Number
- 8001615 FDA UDI
- Primary DI / UDI-DI
- 00842092167199 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental implant suprastructure, temporary, preformed, single-use
3i Certain by PREAT Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- PREAT Corporation
Sources (1)
- FDA UDI e0424b7a-eae7-453a-a598-4cd8133d1e5e 35 fields · synced Jun 1, 2026