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Aidite Pmma Multilayer

by Aidite (Qinhuangdao) Technology Co., Ltd. 185 variants

Aidite Pmma Multilayer 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 24 Apr 2025 (UDI-DI 06977979287760), 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) K190217

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 Number06977979287760 UDI-DI Date24 Apr 2025ListedStatusListed 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 06977979287760 listed 24 Apr 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K190217
  2. Listed FDA GUDID 06977979287760

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Aidite Pmma
Generic name
Dental appliance fabrication material, ceramic
Model / reference
Multilayer
Primary DI / UDI-DI
06977979287760
510(k) Number
FDA product code
EBG
GMDN term
Dental appliance fabrication material, ceramic
Device class
Class II
Regulation number
872.3770
GUDID distribution status
In Commercial Distribution

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Properties

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