Identity
- Trade Name
- Implant Prosthetics FDA UDI
- Generic Name
- Dental prosthesis/implant abutment screw analog, reusable FDA UDI
- Device Name
- BioHorizons®-compatible 4.5mm Digital Analog FDA UDI
- Model / Reference
- 9005503 FDA UDI
- Description
- BioHorizons®-compatible 4.5mm Digital Analog FDA UDI
Identifiers
- Catalog Number
- 9005503 FDA UDI
- Primary DI / UDI-DI
- 00842092137338 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Dental prosthesis/implant abutment screw analog, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Moist Heat or Steam Sterilization FDA UDI
Implant Prosthetics by PREAT Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- PREAT Corporation
Sources (1)
- FDA UDI b0ee2e34-955e-410d-bb4f-02b3b5d4ae9b 36 fields · synced Jun 8, 2026