Ceramic Brackets Orthometric
FDA 510(k) K222847 · Orthometric - Industria E Comercio DE Produtos Medicos
510(k) numberK222847
Submission
- Device name
- Ceramic Brackets Orthometric
- Applicant
- Orthometric - Industria E Comercio DE Produtos Medicos
Marilia, BR - Received
- September 21, 2022
- Decision date
- May 4, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| K232011 | CleoNJM · Traditional | American Orthodontics | 07/07/2023SE |
| K231635 | A-Line AdvancedNJM · Traditional | Biocetec Co., Ltd. | 06/06/2023SE |
| K230225 | DynaFlex Clear Brackets & ButtonsNJM · Traditional | Dyna Flex | 06/05/2023SE |
| 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 |
Questions and answers
When was Ceramic Brackets Orthometric cleared by the FDA?
Ceramic Brackets Orthometric (K222847) received a 510(k) decision of Substantially Equivalent on May 4, 2023, 225 days after the submission was received.
What is the product code of K222847?
The FDA product code is NJM – Bracket, Ceramic, Orthodontic, a Class II (moderate risk) device regulated under 21 CFR 872.5470.