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Accent PA0462H

by Orthoquest, Inc.

Accent PA0462H is a Class II device made by Orthoquest, Inc., cleared under FDA 510(k) K052245 on 23 Sep 2005 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 10817713022185), 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) K052245

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 Number10817713022185 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK052245 Date23 Sep 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K052245 decided 23 Sep 2005 Active
  • FDA GUDID UDI-DI 10817713022185 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K052245
  2. Listed FDA GUDID 10817713022185

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Accent
Generic name
Orthodontic bracket, ceramic
Model / reference
PA0462H
Primary DI / UDI-DI
10817713022185
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 (K052245)

and 8 more cleared under K052245

Other devices from Orthoquest, Inc.

See all devices from Orthoquest, Inc. →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)