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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 11 Sep 2024 (UDI-DI 06977585883837), active as of 21 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 21 Oct 2026

Documents

510(k) K192723

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 21 Oct 2026.

Regulatory status

as of registry sync 21 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06977585883837 UDI-DI Date11 Sep 2024ListedStatusListed 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 06977585883837 listed 11 Sep 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K192723
  2. Listed FDA GUDID 06977585883837

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  • Withdrawn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
06977585883837
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)