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Aidite

by Aidite (Qinhuangdao) Technology Co., Ltd. 406 variants

Aidite is a Class II device made by Aidite (Qinhuangdao) Technology Co., Ltd., cleared under FDA 510(k) K192723 on 18 Aug 2020 and listed in FDA GUDID since 28 May 2025 (UDI-DI 06977585888870), active as of 1 Jun 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 1 Jun 2026

Documents

510(k) K192723

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 1 Jun 2026.

Regulatory status

as of registry sync 1 Jun 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06977585888870 UDI-DI Date28 May 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK192723 Date18 Aug 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K192723 decided 18 Aug 2020 Active
  • FDA GUDID UDI-DI 06977585888870 listed 28 May 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K192723
  2. Listed FDA GUDID 06977585888870

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Dental prosthesis dye
Model / reference
Aidite
Primary DI / UDI-DI
06977585888870
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 (K192723)

and 8 more cleared under K192723

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)