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Odp Facebow M500-104

by G&H Wire Company, Inc.

Odp Facebow M500-104 is a Class II device made by G&H Wire Company, Inc., cleared under FDA 510(k) K111169 on 3 Oct 2011 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 10190886000076), 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) K111169

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 Number10190886000076 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK111169 Date3 Oct 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K111169 decided 3 Oct 2011 Active
  • FDA GUDID UDI-DI 10190886000076 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K111169
  2. Listed FDA GUDID 10190886000076

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Odp Facebow
Generic name
Orthodontic face bow
Model / reference
M500-104
Primary DI / UDI-DI
10190886000076
510(k) Number
FDA product code
DZB
GMDN term
Orthodontic face bow
Device class
Class II
Regulation number
872.5500
GUDID distribution status
In Commercial Distribution

Related devices

Category: Orthodontic face bow

Cleared under the same submission (K111169)

and 8 more cleared under K111169

Other devices from G&H Wire Company, Inc.

See all devices from G&H Wire Company, Inc. →

Properties

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