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Zenith™ Roth Composite Brackets (Kit) KTRCM2355P

by G&H Wire Company, Inc.

Zenith™ Roth Composite Brackets (Kit) KTRCM2355P is a Class II device made by G&H Wire Company, Inc., cleared under FDA 510(k) K973776 on 21 Nov 1997 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 10190886009062), 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) K973776

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 Number10190886009062 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK973776 Date21 Nov 1997DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K973776 decided 21 Nov 1997 Active
  • FDA GUDID UDI-DI 10190886009062 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K973776
  2. Listed FDA GUDID 10190886009062

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Zenith™ Roth Composite Brackets (Kit)
Generic name
Orthodontic bracket, plastic, single-use
Model / reference
KTRCM2355P
Primary DI / UDI-DI
10190886009062
510(k) Number
FDA product code
DYW
GMDN term
Orthodontic bracket, plastic, single-use
Device class
Class II
Regulation number
872.5470
GUDID distribution status
In Commercial Distribution

Related devices

Category: Orthodontic bracket, plastic, single-use

Cleared under the same submission (K973776)

and 8 more cleared under K973776

Other devices from G&H Wire Company, Inc.

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

Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Manufacturing date
Other properties (10, all answered No)