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Cleo 002-22-000009HM

by American Orthodontics 2 variants

Cleo 002-22-000009HM, an orthodontic bracket (FDA Class II; FDA product code NJM, Bracket, ceramic, orthodontic) made by American Orthodontics, was cleared under FDA 510(k) K232011 on 7 Jul 2023 and listed in FDA GUDID on 14 Jan 2025 (UDI-DI 00190746064456); the registry lists it as not in commercial distribution (GUDID) as of 23 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

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) K232011

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 Number00190746064456 UDI-DI Date14 Jan 2025ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK232011 Date7 Jul 2023DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K232011 decided 7 Jul 2023 Active
  • FDA GUDID UDI-DI 00190746064456 listed 14 Jan 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K232011
  2. Listed FDA GUDID 00190746064456

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Cleo
Generic name
Orthodontic bracket, ceramic
Model / Ref / Catalog
002-22-000009HM
Primary DI / UDI-DI
00190746064456
510(k) Number
FDA product code
NJM
GMDN term
Orthodontic bracket, ceramic
Device class
Class II
Regulation number
872.5470
GUDID distribution status
Not in Commercial Distribution
MRI safety
MR Safe

Similar devices

Other devices filed under FDA product code NJM (Bracket, ceramic, orthodontic).

Other devices from American Orthodontics

See all devices from American Orthodontics →

Properties

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