Identity
- Trade Name
- Tru-Stain FDA UDI
- Generic Name
- Temporary dental crown/bridge resin FDA UDI
- Device Name
- Tru-Stains are colored acrylic powder, that are applied by brush to modify the shades of provisional and permanent acrylic. The stains are applied to heat cured acrylic restorations. FDA UDI
- Model / Reference
- Brown - 3 gm FDA UDI
- Description
- Tru-Stains are colored acrylic powder, that are applied by brush to modify the shades of provisional and permanent acrylic. The stains are applied to heat cured acrylic restorations. FDA UDI
Identifiers
- Catalog Number
- 01-2905 FDA UDI
- Primary DI / UDI-DI
- D8370129050 FDA UDI
- FDA Product Code
- EBD FDA UDI
- GMDN Term
- Temporary dental crown/bridge resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3310 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
Yes
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
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — 3 Gram FDA UDI
Category: Temporary dental crown/bridge resin
Tru-Stain by Taub Products — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Temporary dental crown/bridge resin.
- Alpha-Crown® — Dental Technologies, Inc. · Class II
- JET TOOTH SHADE POWDER — Lang Dental Manufacturing Company, Inc. · Class II
- UNIFAST™ — Gc America Inc. · Class II
- MODIFYING STAIN — AMERICAN TOOTH INDUSTRIES · Class II
- DENTURE BASE — AMERICAN TOOTH INDUSTRIES · Class II
- PORTUX CAD/CAM Disc. 98.5X 25mm C2. MN — PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A · Class II
- tempofit premium BL — DETAX GmbH · Class II
- YAMAHACHI PMMA DISK — YAMAHACHI DENTAL MFG., CO. · Class II
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
- Taub Products
Sources (1)
- FDA UDI e77b54d1-f4ea-42f1-943f-8dad7f844037 37 fields · synced May 30, 2026