Identity
- Trade Name
- Preat FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- Multi-Unit Titanium Base w/.050 Screw. Kit Contains:. 1 Multi-Unit Titanium Base (00842092155356). 2 Multi-Unit Titanium Screws (00842092165287) FDA UDI
- Model / Reference
- 9003760 FDA UDI
- Description
- Multi-Unit Titanium Base w/.050 Screw. Kit Contains:. 1 Multi-Unit Titanium Base (00842092155356). 2 Multi-Unit Titanium Screws (00842092165287) FDA UDI
Identifiers
- Catalog Number
- 9003760 FDA UDI
- Primary DI / UDI-DI
- 00842092165331 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
- Not 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
Yes
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
Preat by PREAT Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K183518 also covers:
- Clix Ball Implant Abutments — PREAT Corporation
- Clix Ball Implant Abutments — PREAT Corporation
- Implant Prosthetics — PREAT Corporation
- Implant Prosthetics — PREAT Corporation
- Implant Prosthetics — PREAT Corporation
- Implant Prosthetics — PREAT Corporation
- Implant Prosthetics — PREAT Corporation
- Implant Prosthetics — PREAT Corporation
- Implant Prosthetics — PREAT Corporation
- Implant Prosthetics — PREAT Corporation
- Implant Prosthetics — PREAT Corporation
- Implant Prosthetics — PREAT Corporation
K220823 also covers:
- Implant Prosthetics — PREAT Corporation
- Implant Prosthetics — PREAT Corporation
- Preat Implant Prosthetics — PREAT Corporation
- Preat Implant Prosthetics — PREAT Corporation
- Preat Implant Prosthetics — PREAT Corporation
- Preat Implant Prosthetics — PREAT Corporation
- Preat Implant Prosthetics — PREAT Corporation
- Preat Implant Prosthetics — PREAT Corporation
- Preat Implant Prosthetics — PREAT Corporation
- Preat Implant Prosthetics — PREAT Corporation
- Preat Implant Prosthetics — PREAT Corporation
- Preat Implant Prosthetics — PREAT Corporation
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- PREAT Corporation
Sources (1)
- FDA UDI b824567a-5c70-4b70-bbdd-6e71fea6a035 37 fields · synced Jun 8, 2026