Identity
- Trade Name
- Tru-Paque FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Masks out metal partial framework, veneers, copings & bridgework. 5 - 7 micron film thickness. Air dries in 15 seconds. Does not affect undercuts. Opaques Monomer/powder acrylic systems. Use all colors (except Pink) on Labial / buccal metal surface prior to placement of acrylic or other resin. FDA UDI
- Model / Reference
- Dark Yellow - 50 mL FDA UDI
- Description
- Masks out metal partial framework, veneers, copings & bridgework. 5 - 7 micron film thickness. Air dries in 15 seconds. Does not affect undercuts. Opaques Monomer/powder acrylic systems. Use all colors (except Pink) on Labial / buccal metal surface prior to placement of acrylic or other resin. FDA UDI
Identifiers
- Catalog Number
- 07-2031 FDA UDI
- Primary DI / UDI-DI
- D8370720310 FDA UDI
- FDA Product Code
- EBF FDA UDI
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3690 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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 50 Milliliter FDA UDI
Category: Dental composite resin
Tru-Paque by Taub Products — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 d6b8cb28-420e-4c70-a5d2-b7cd75bc6d9f 37 fields · synced May 30, 2026