Cleo
FDA 510(k) K232011 · American Orthodontics
510(k) numberK232011
Submission
- Device name
- Cleo
- Applicant
- American Orthodontics
Sheboygan, WI, US - Received
- July 6, 2023
- Decision date
- July 7, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- NJM – Bracket, Ceramic, Orthodontic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.5470
- Specialty
- Dental
An orthodontic ceramic bracket is a device composed of ceramic, which is intended to be bonded to a tooth, upon which an orthodontic wire is used to move the tooth to a new position.
Other 510(k)s with product code NJM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232827 | LightForce Orthodontic SystemNJM · Traditional | Lightforce Orthodontics | 09/14/2023SE |
| K231635 | A-Line AdvancedNJM · Traditional | Biocetec Co., Ltd. | 06/06/2023SE |
| K230225 | DynaFlex Clear Brackets & ButtonsNJM · Traditional | Dyna Flex | 06/05/2023SE |
| K222847 | Ceramic Brackets OrthometricNJM · Traditional | Orthometric - Industria E Comercio DE Produtos… | 05/04/2023SE |
| K222764 | LightForce Orthodontic SystemNJM · Special | Lightforce Orthodontics | 09/14/2022SE |
| K220689 | Vatech ClismileNJM · Traditional | Rayence Co., Ltd. | 05/06/2022SE |
| K201410 | VENUS Bracket, ROSE BracketNJM · Traditional | Gni Co., Ltd. | 03/12/2021SE |
| K201038 | Luce Ceramic BracketNJM · Traditional | Luce Castle Co., Ltd. | 10/09/2020SE |
| K200148 | LightForce Orthodontic System (LFO System)NJM · Traditional | Lightforce Orthodontics | 02/21/2020SE |
| K182672 | ROSA BracketNJM · Traditional | Gni Co., Ltd. | 11/15/2019SE |
More from Gni Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K261840 | BracePaste Prime PlusDYH · Traditional | 06/03/2026SE |
| K242537 | BracePaste Fluoride SealantDYH · Traditional | 08/27/2024SE |
| K202276 | BracePaste Band and Build LCDYH · Traditional | 08/14/2020SE |
| K181910 | BracePaste MTP Light Cure PrimerKLE · Traditional | 10/15/2018SE |
| K172953 | Acid EtchantKLE · Traditional | 02/06/2018SE |
| K160782 | BracePaste AdhesiveDYH · Traditional | 10/14/2016SE |
| K143117 | Wire Sterilization Package with IndicatorsFRG · Traditional | 10/29/2015SE |
| K122753 | Empower ClearNJM · Traditional | 12/14/2012SE |
| K080749 | RadianceNJM · Traditional | 08/04/2008SE |
| K925012 | Plastic ChainEJF · Traditional | 09/13/1993SE |
Questions and answers
When was Cleo cleared by the FDA?
Cleo (K232011) received a 510(k) decision of Substantially Equivalent on July 7, 2023, 1 days after the submission was received.
What is the product code of K232011?
The FDA product code is NJM – Bracket, Ceramic, Orthodontic, a Class II (moderate risk) device regulated under 21 CFR 872.5470.