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Encore! MC-874

by Ortho Technology, Inc.

Encore! MC-874 is a Class II device made by Ortho Technology, Inc., cleared under FDA 510(k) K922499 on 30 Jul 1992 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00190730005366), 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 ongoing

1 closed

Documents

510(k) K922499

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 Number00190730005366 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK922499 Date30 Jul 1992DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K922499 decided 30 Jul 1992 Active
  • FDA GUDID UDI-DI 00190730005366 listed 24 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-0876-2013 FDA Class III initiated 8 Feb 2013 on shared 510(k) K922499

    Orthodontic brackets distributed was incorrectly labeled.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

3 dated events

  1. Cleared FDA 510(k) K922499
  2. Recall initiated FDA recalls Z-0876-2013
  3. Listed FDA GUDID 00190730005366

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Encore!
Generic name
Orthodontic bracket, ceramic
Model / reference
MC-874
Primary DI / UDI-DI
00190730005366
510(k) Number
FDA product code
NJM
GMDN term
Orthodontic bracket, ceramic
Device class
Class II
Regulation number
872.5470
GUDID distribution status
In Commercial Distribution

Related devices

Category: Orthodontic bracket, ceramic

Cleared under the same submission (K922499)

and 8 more cleared under K922499

Other devices from Ortho Technology, Inc.

See all devices from Ortho Technology, Inc. →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)