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Reflections REF-830

by Ortho Technology, Inc.

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00190730006158 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK922499 Date30 Jul 1992DecidedStatusActive

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.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Reflections
Generic name
Orthodontic bracket, ceramic
Model / reference
REF-830
Primary DI / UDI-DI
00190730006158
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)

Show all (12)

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)

  • Supplied sterile: No
  • Sterilise before use: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No