Identity
- Trade Name
- Z-TEMP FDA UDI
- Generic Name
- Temporary dental crown/bridge FDA UDI
- Device Name
- Z-TEMP PMMA DISK MULTILAYER COLOR A3 98,5/16mm FDA UDI
- Model / Reference
- DISK A3 MULTI 98,5/16mm FDA UDI
- Description
- Z-TEMP PMMA DISK MULTILAYER COLOR A3 98,5/16mm FDA UDI
Identifiers
- Catalog Number
- Z-4516/A3 FDA UDI
- Primary DI / UDI-DI
- 08435288476568 FDA UDI
- 510(k) Number
- K150432 FDA UDI
- FDA Product Code
- EBG FDA UDI
- GMDN Term
- Temporary dental crown/bridge FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3770 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Temporary dental crown/bridge
Z-Temp by Union Dental Sa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Temporary dental crown/bridge.
- Visalys Temp — Kettenbach GmbH & Co. KG · Class II
- artBloc Temp — Merz Dental GmbH · Class II
- VIPI BLOCK — Vipi Indústria, Comércio, Exportação e Importação de Produtos Odontológicos Ltda. · Class II
- VIPI BLOCK — Vipi Indústria, Comércio, Exportação e Importação de Produtos Odontológicos Ltda. · Class II
- Pure PMMA Disc — QUEST DENTAL MATERIAL CORPORATION · Class II
- Pure PMMA Disc — QUEST DENTAL MATERIAL CORPORATION · Class II
- Pure PMMA Disc — QUEST DENTAL MATERIAL CORPORATION · Class II
- ACRY ROCK — Vipi Indústria, Comércio, Exportação e Importação de Produtos Odontológicos Ltda. · Class II
Cleared under the same submission
K150432 also covers:
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
- Union Dental Sa
Sources (1)
- FDA UDI d23792f2-0a11-4701-b52e-604b24b2acb4 35 fields · synced Jun 1, 2026