Identity
- Trade Name
- TEMP TABS FDA UDI
- Generic Name
- Composite dental impression material FDA UDI
- Device Name
- FLEXIBLE MATRIX FOR FABRICATING TEMPORARY CROWNS AND BRIDGES AND BITE REGISTRATIONS FDA UDI
- Model / Reference
- 143033 FDA UDI
- Description
- FLEXIBLE MATRIX FOR FABRICATING TEMPORARY CROWNS AND BRIDGES AND BITE REGISTRATIONS FDA UDI
Identifiers
- Primary DI / UDI-DI
- D0331430330 FDA UDI
- 510(k) Number
- K033227 FDA UDI
- FDA Product Code
- EBG FDA UDI
- GMDN Term
- Composite dental impression material 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Composite dental impression material
Temp Tabs by DMG America LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Composite dental impression material.
- Accusil Heavy Body — PREVEST DENPRO LIMITED · Class II
- Patterson® — PATTERSON DENTAL SUPPLY, INC. · Class II
- Patterson® — PATTERSON DENTAL SUPPLY, INC. · Class II
- Bosworth Sapphire — Harry J. Bosworth Co. · Class II
- UltraSil Putty 1000 — Dsi Dental Solutions, Ltd. · Class II
- Accusil Monophase — PREVEST DENPRO LIMITED · Class II
- Patterson® — PATTERSON DENTAL SUPPLY, INC. · Class II
- Bosworth Superbite — Harry J. Bosworth Co. · Class II
Cleared under the same submission
K033227 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
- DMG America LLC
Sources (1)
- FDA UDI f780cf90-0edf-4a4c-9f0c-b3529479297d 35 fields · synced Jun 6, 2026