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Illuminate 471-050

by Ortho Organizers, Inc.

Illuminate 471-050 is a Class II device made by Ortho Organizers, Inc., cleared under FDA 510(k) K935625 on 10 Aug 1994 and listed in FDA GUDID since 30 Sep 2019 (UDI-DI 00190707041229), 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) K935625

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 Number00190707041229 UDI-DI Date30 Sep 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK935625 Date10 Aug 1994DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K935625 decided 10 Aug 1994 Active
  • FDA GUDID UDI-DI 00190707041229 listed 30 Sep 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K935625
  2. Listed FDA GUDID 00190707041229

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Illuminate
Generic name
Orthodontic bracket adhesive
Model / reference
471-050
Primary DI / UDI-DI
00190707041229
510(k) Number
FDA product code
DYH
GMDN term
Orthodontic bracket adhesive
Device class
Class II
Regulation number
872.3750
GUDID distribution status
In Commercial Distribution

Related devices

Category: Orthodontic bracket adhesive

Cleared under the same submission (K935625)

and 8 more cleared under K935625

Other devices from Ortho Organizers, Inc.

See all devices from Ortho Organizers, Inc. →

Properties

  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)