Skip to content

Aidite Color

by Aidite (Qinhuangdao) Technology Co., Ltd. 902 variants

Aidite Color is a Class II device made by Aidite (Qinhuangdao) Technology Co., Ltd., cleared under FDA 510(k) K190217 on 17 Dec 2020 and listed in FDA GUDID since 8 Feb 2023 (UDI-DI 06934906622964), 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) K190217

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 Number06934906622964 UDI-DI Date8 Feb 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK190217 Date17 Dec 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K190217 decided 17 Dec 2020 Active
  • FDA GUDID UDI-DI 06934906622964 listed 8 Feb 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K190217
  2. Listed FDA GUDID 06934906622964

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  • Withdrawn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
Temporary dental crown/bridge resin
Model / reference
Color
Primary DI / UDI-DI
06934906622964
510(k) Number
FDA product code
EBG
GMDN term
Temporary dental crown/bridge resin
Device class
Class II
Regulation number
872.3770
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under Temporary dental crown/bridge resin.

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)