Identity
- Trade Name
- Preat Implant Prosthetics FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Biomet 3i Certain®-compatible 4.1mm – Milled Ti Abutment Kit contains: 1 Biomet 3i Certain®-compatible 4.1mm – Milled Ti Abutment 2 Biomet 3i Certain®-compatible 3.4mm/4.1mm/5.0mm/6.0mm Titanium Implant Screws FDA UDI
- Model / Reference
- 9001767-F FDA UDI
- Description
- Biomet 3i Certain®-compatible 4.1mm – Milled Ti Abutment Kit contains: 1 Biomet 3i Certain®-compatible 4.1mm – Milled Ti Abutment 2 Biomet 3i Certain®-compatible 3.4mm/4.1mm/5.0mm/6.0mm Titanium Implant Screws FDA UDI
Identifiers
- Catalog Number
- 9001767-F FDA UDI
- Primary DI / UDI-DI
- 00842092166109 FDA UDI
- 510(k) Number
- K183518 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant suprastructure, permanent, preformed 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Dental implant suprastructure, permanent, preformed
Preat Implant Prosthetics by PREAT Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, permanent, preformed.
- SPARE CAST. SLEEVE FOR — SWEDEN & MARTINA INC · Class II
- HS/HG Prosthetic System — OSSTEM IMPLANT Co., Ltd. · Class II
- DESS dental smart solutions — TERRATS MEDICAL SL. · Class II
- Diamodent — Diamodent · Class II
- Cemented Abutment — POINTIMPLANT Co., Ltd. · Class II
- GS System — OSSTEM IMPLANT Co., Ltd. · Class II
- Temporary Abutment — Cybermed Inc. · Class II
- EZ Post — Megagen Implant Co. Ltd · Class II
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
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
- PREAT Corporation
Sources (1)
- FDA UDI 53555d04-3c3a-4778-a079-fceb2b4f067d 35 fields · synced May 31, 2026