Glossy Coat

Glossy Coat is a light cured coating for resin based dental prostheses such as crowns, bridges and dentures. It is applied to the surface to improve smoothness and wear resistance, either…

Registry build 21.09.26

Glossy Coat is a light cured coating for resin based dental prostheses such as crowns, bridges and dentures. It is applied to the surface to improve smoothness and wear resistance, either in the mouth or on a working model.

The liquid contains multifunctional acrylate, methyl methacrylate, silica filler and a photoinitiator. Compatible LED light sources harden the coating after application, producing a glossy surface finish.

Light Curing

The effective curing wavelength range is 365 to 410 nm. Specified curing times depend on the light unit: three minutes with the listed laboratory LED source or 20 seconds with the listed chairside LED source. The selected curing equipment determines the applicable timing.

1manufacturer
1catalogue number
1510(k) clearance

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 Glossy Coat
Listed by Yamahachi Dental MFG. Co., Japan
FDA product code EBD
Device type Coating, Filling Material, Resin
Device class Class 2
Regulation 21 CFR 872.3310
Establishment Specification developer, Complaint-file establishment, Manufacturer
510(k) K254091
Record published 2026-04-10

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for Glossy Coat
Catalogue number Size Status
15ML In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
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Renamel® Flowable Microfill Cosmedent, Inc. 26
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Glaze Taub Products 14
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Showing 12 of 100. All products under Coating, Filling Material, Resin

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K254091 2026-04-06

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