NJM — Bracket, Ceramic, Orthodontic Class II
FDA product code NJM covers "Bracket, Ceramic, Orthodontic", a Class II medical device regulated under 21 CFR 872.5470. Submissions are reviewed by the Dental panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NJM
- Device Class
- Class II
- Regulation Number
- 872.5470
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Definition
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K232827 | lightforce orthodontics | LightForce Orthodontic System | September 14, 2023 |
| K232011 | american orthodontics | Cleo | July 7, 2023 |
| K231635 | biocetec co | A-Line Advanced | June 6, 2023 |
| K230225 | dyna flex | DynaFlex Clear Brackets & Buttons | June 5, 2023 |
| K222847 | orthometric - industria e comercio de produtos medicos | Ceramic Brackets Orthometric | May 4, 2023 |
| K222764 | lightforce orthodontics | LightForce Orthodontic System | September 14, 2022 |
| K220689 | rayence co | Vatech Clismile | May 6, 2022 |
| K201410 | gni co | VENUS Bracket, ROSE Bracket | March 12, 2021 |
| K201038 | luce castle co | Luce Ceramic Bracket | October 9, 2020 |
| K200148 | lightforce orthodontics | LightForce Orthodontic System (LFO System) | February 21, 2020 |
| K182672 | gni co | ROSA Bracket | November 15, 2019 |
| K192202 | world class technology corporation | Clear21 | November 12, 2019 |
| K190608 | orthosun co | Mei Ceramic Bracket | November 4, 2019 |
| K180952 | mem dental technology co | Ceramic Bracket | June 7, 2019 |
| K182193 | biocetec co | S-Line | January 22, 2019 |
| K183542 | signature orthodontics | Signature Orthodontic System | January 2, 2019 |
| K181271 | signature orthodontics | Signature Orthodontic System | June 13, 2018 |
| K180404 | 3m healthcare | 3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System | March 16, 2018 |
| K173440 | ortho organizers | Carriere SLX 3D Clear | March 8, 2018 |
| K172845 | ormco corporation | Symetri Clear | January 31, 2018 |