Identity
- Trade Name
- Preat FDA UDI
- Generic Name
- Dental prosthesis/implant abutment screw analog, single-use FDA UDI
- Device Name
- O-Ring Mini Implant Impression Coping FDA UDI
- Model / Reference
- 1500212 FDA UDI
- Description
- O-Ring Mini Implant Impression Coping FDA UDI
Identifiers
- Catalog Number
- 1500212 FDA UDI
- Primary DI / UDI-DI
- 00842092166864 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Dental prosthesis/implant abutment screw analog, 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
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Moist Heat or Steam Sterilization FDA UDI
Category: Dental prosthesis/implant abutment screw analog, single-use
Preat by PREAT Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental prosthesis/implant abutment screw analog, single-use.
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- ACE — ACE SURGICAL SUPPLY CO., INC. · Class II
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- Paltop — Paltop Advanced Dental Solutions, Ltd. · Class I
- Pick-up Impression Coping — Izenimplant Co., Ltd. · Class I
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 c6596250-a425-4b1d-80b9-63f1b8195ada 35 fields · synced May 29, 2026