FDA.reportPublic FDA data

510(k) K232011

Device
Cleo
Applicant
American Orthodontics
510(k) number
K232011
Product code
NJM
Decision
Substantially Equivalent (SESE)
Decision date
2023-07-07
Date received
2023-07-06
Regulation
872.5470
Classification name
Bracket, Ceramic, Orthodontic
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
Yes

Applicant Contact#

Contact
Laura Richmond
Address
3524 Washington Ave. Sheboygan WI US 53081 53081

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NJM#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K232827LightForce Orthodontic SystemLightforce Orthodontics2023-09-14
K231635A-Line AdvancedBiocetec Co., Ltd.2023-06-06
K230225DynaFlex Clear Brackets & ButtonsDyna Flex2023-06-05
K222847Ceramic Brackets OrthometricOrthometric - Industria E Comercio DE Produtos Medicos2023-05-04
K222764LightForce Orthodontic SystemLightforce Orthodontics2022-09-14
K220689Vatech ClismileRayence Co., Ltd.2022-05-06
K201410VENUS Bracket, ROSE BracketGni Co., Ltd.2021-03-12
K201038Luce Ceramic BracketLuce Castle Co., Ltd.2020-10-09
K200148LightForce Orthodontic System (LFO System)Lightforce Orthodontics2020-02-21
K182672ROSA BracketGni Co., Ltd.2019-11-15
K192202Clear21World Class Technology Corporation2019-11-12
K190608Mei Ceramic BracketOrthosun Co., Ltd.2019-11-04
K180952Ceramic BracketMem Dental Technology Co., Ltd.2019-06-07
K182193S-LineBiocetec Co., Ltd.2019-01-22
K183542Signature Orthodontic SystemSignature Orthodontics2019-01-02