Tru-Stain

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.

Registry build 21.09.26
1manufacturer
7catalogue numbers in this listing

Who Else Makes It

Registered in Jiangsu.

Chinese manufacturers registered for FDA product code EBD
Manufacturer City Province Registered as Device types
Yamahachi Dental Material (Changshu) Co., Ltd. Changshu Jiangsu Manufacturer 9

Record

Regulatory record for Tru-Stain
Listed by Taub Products
FDA product code EBD
Device type Coating, Filling Material, Resin
Device class Class 2
Regulation 21 CFR 872.3310
Premarket notification Exempt
Record published 2016-12-19
Record revised 2025-07-14 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Supplied as a kit Yes
Label carries lot or batch number
Storage Special storage condition: Keep away from open flame. See SDS.
Sizes Weight 3 g

Catalogue Numbers

Catalogue numbers for Tru-Stain
Catalogue number Size Status
Cervical Blend – 3 gm Weight 3 g In distribution
White – 3 gm Weight 3 g In distribution
Yellow – 3 gm Weight 3 g In distribution
Blue – 3 gm Weight 3 g In distribution
Pink – 3 gm Weight 3 g In distribution
Grey – 3 gm Weight 3 g In distribution
Brown – 3 gm Weight 3 g In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
ID Lightcure System ID Korea Co., Ltd. 63
Minute Stain Taub Products 56
Optiglaze™ GC America Inc. 44
Rodin PAC-Dent Inc. 39
Renamel® Flowable Microfill Deltamed Gmbh 27
Vita Akzent® LC Vita – Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft 27
Renamel® Flowable Microfill Cosmedent, Inc. 26
Radica® Dentsply LLC 20
SciPharm Support Self Cured Core Build-Up Restorative Reverse Scientific Pharmaceuticals, Inc. 18
Renamel® Flowable Microhybrid Cosmedent, Inc. 16
Glaze Taub Products 14
Signum matrix Kulzer SRL 14

Showing 12 of 100. All products under Coating, Filling Material, Resin

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer