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Glossy Coat 15ml

by Yamahachi Dental Mfg., Co.

Glossy Coat 15ml is a Class II device made by Yamahachi Dental Mfg., Co., cleared under FDA 510(k) K254091 on 6 Apr 2026 and listed in FDA GUDID since 10 Apr 2026 (UDI-DI D080XXGCO15MLXXXXX0), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K254091

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD080XXGCO15MLXXXXX0 UDI-DI Date10 Apr 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK254091 Date6 Apr 2026DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K254091 decided 6 Apr 2026 Active
  • FDA GUDID UDI-DI D080XXGCO15MLXXXXX0 listed 10 Apr 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K254091
  2. Listed FDA GUDID D080XXGCO15MLXXXXX0

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Glossy Coat
Generic name
Dental unfilled resin sealant/coating
Model / reference
15ML
Primary DI / UDI-DI
D080XXGCO15MLXXXXX0
510(k) Number
FDA product code
EBD
GMDN term
Dental unfilled resin sealant/coating
Device class
Class II
Regulation number
872.3310
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code EBD (Coating, Filling Material, Resin).

Other devices from Yamahachi Dental Mfg., Co.

See all devices from Yamahachi Dental Mfg., Co. →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)