Identity
- Trade Name
- Zimmer FDA UDI
- Generic Name
- Dental prosthesis/implant abutment screw FDA UDI
- Device Name
- Zimmer® TSV-compatible 3.5mm Closed-Tray Transfer Screw FDA UDI
- Model / Reference
- 8000106 FDA UDI
- Description
- Zimmer® TSV-compatible 3.5mm Closed-Tray Transfer Screw FDA UDI
Identifiers
- Catalog Number
- 8000106 FDA UDI
- Primary DI / UDI-DI
- 00842092100233 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Dental prosthesis/implant abutment screw 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
Moist Heat or Steam Sterilization FDA UDI
Category: Dental prosthesis/implant abutment screw
Zimmer 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.
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- INNO Submerged Implant System-Cemented Abutment — Cowellmedi Co., Ltd · Class II
- MEDENTiKA — Medentika GmbH · Class II
- Azure — TERRATS MEDICAL SL. · Class II
- Recharge Kit w/ POC, TiLobe — SMART DENTURE CONVERSIONS, LLC · 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 8381b9d8-5167-4aac-953e-1f1b477e96bf 34 fields · synced May 31, 2026