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Aidite Stain/Glaze

by Aidite (Qinhuangdao) Technology Co., Ltd. 83 variants

Aidite Stain/Glaze is a Class II device made by Aidite (Qinhuangdao) Technology Co., Ltd., cleared under FDA 510(k) K011425 on 5 Jun 2001 and listed in FDA GUDID since 15 Apr 2023 (UDI-DI 06976029569696), active as of 23 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 23 Oct 2026

Documents

510(k) K011425

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06976029569696 UDI-DI Date15 Apr 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK011425 Date5 Jun 2001DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K011425 decided 5 Jun 2001 Active
  • FDA GUDID UDI-DI 06976029569696 listed 15 Apr 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K011425
  2. Listed FDA GUDID 06976029569696

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Aidite
Generic name
Dental prosthesis dye
Model / reference
Stain/Glaze
Primary DI / UDI-DI
06976029569696
510(k) Number
FDA product code
EIH
GMDN term
Dental prosthesis dye
Device class
Class II
Regulation number
872.6660
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental prosthesis dye

Cleared under the same submission (K011425)

and 8 more cleared under K011425

Other devices from Aidite (Qinhuangdao) Technology Co., Ltd.

See all devices from Aidite (Qinhuangdao) Technology Co., Ltd. →

Properties

  • Single use
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)