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Cleo

by American Orthodontics

510(k) K232011

Cleo is an orthodontic bracket (FDA Class II; FDA product code NJM, Bracket, Ceramic, Orthodontic) made by American Orthodontics, cleared under FDA 510(k) K232011 on 7 Jul 2023 and listed in FDA GUDID since 14 Jan 2025 (UDI-DI 00190746064449), active (FDA 510(k)), not in commercial distribution (GUDID) as of 22 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 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00190746064449 UDI-DI Date14 Jan 2025ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK232011 Date7 Jul 2023ClearedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K232011 decided 7 Jul 2023 Active
  • FDA GUDID UDI-DI 00190746064449 listed 14 Jan 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K232011
  2. Listed FDA GUDID 00190746064449

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k) · GUDID

Generic name
Orthodontic bracket, ceramic
Model / Ref / Catalog
002-22-000010HD
Primary DI / UDI-DI
00190746064449
510(k) Number
FDA product code
NJM
GMDN term
Orthodontic bracket, ceramic
Device class
Class II
Regulation
21 CFR Part 872.5470
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent
GUDID distribution status
Not in Commercial Distribution
MRI safety
MR Safe

Devices cleared under K232011

12 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K232011
UDI-DISize and differences
Cleo 002-18-000009
American Orthodontics
002-18-000009 / 002-18-00000900190746061356 —No longer on the market
Cleo 002-18-000009HD
American Orthodontics
002-18-000009HD / 002-18-000009HD00190746064364 —No longer on the market
Cleo 002-18-000009HM
American Orthodontics
002-18-000009HM / 002-18-000009HM00190746064388 —No longer on the market
Cleo 002-18-000010
American Orthodontics
002-18-000010 / 002-18-00001000190746064340 —No longer on the market
Cleo 002-18-000010HD
American Orthodontics
002-18-000010HD / 002-18-000010HD00190746064371 —No longer on the market
Cleo 002-18-000010HM
American Orthodontics
002-18-000010HM / 002-18-000010HM00190746064401 —No longer on the market
Cleo 002-22-000009
American Orthodontics
002-22-000009 / 002-22-00000900190746064418 —No longer on the market
Cleo 002-22-000009HD
American Orthodontics
002-22-000009HD / 002-22-000009HD00190746064432 —No longer on the market
Cleo 002-22-000009HM
American Orthodontics
002-22-000009HM / 002-22-000009HM00190746064456 —No longer on the market
Cleo 002-22-000010
American Orthodontics
002-22-000010 / 002-22-00001000190746064425 —No longer on the market
Cleo 002-22-000010HD
American Orthodontics
002-22-000010HD / 002-22-000010HD00190746064449 —No longer on the market
Cleo 002-22-000010HM
American Orthodontics
002-22-000010HM / 002-22-000010HM00190746064470 —No longer on the market

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)