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Orthoquest K0123

by Young Innovations, Inc.

Orthoquest K0123 is a Class II device made by Young Innovations, Inc., cleared under FDA 510(k) K940120 on 25 Feb 1994 and listed in FDA GUDID since 24 Nov 2022 (UDI-DI 00840326406557), 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) K940120

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 Number00840326406557 UDI-DI Date24 Nov 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK940120 Date25 Feb 1994DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K940120 decided 25 Feb 1994 Active
  • FDA GUDID UDI-DI 00840326406557 listed 24 Nov 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K940120
  2. Listed FDA GUDID 00840326406557

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Orthoquest
Generic name
Alginate dental impression material
Model / Ref / Catalog
K0123
Primary DI / UDI-DI
00840326406557
510(k) Number
FDA product code
ELW
GMDN term
Alginate dental impression material
Device class
Class II
Regulation number
872.3660
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code ELW (MATERIAL, IMPRESSION).

Other devices from Young Innovations, Inc.

See all devices from Young Innovations, Inc. →

Properties

  • Single use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)