NJM · Bracket, Ceramic, Orthodontic
Dental · 21 CFR 872.5470 · Class 2
Overview
| Product Code | NJM |
|---|---|
| Device Name | Bracket, Ceramic, Orthodontic |
| Regulation | 21 CFR 872.5470 |
| Device Class | Class 2 |
| Review Panel | Dental |
| 3rd-Party Reviewable | Yes |
Identification
An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 60)
Showing 20 most recent of 60 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K232827 | LightForce Orthodontic System | Lightforce Orthodontics | Sep 14, 2023 | SESE |
| K232011 | Cleo | American Orthodontics | Jul 7, 2023 | SESE |
| K231635 | A-Line Advanced | Biocetec Co., Ltd. | Jun 6, 2023 | SESE |
| K230225 | DynaFlex Clear Brackets & Buttons | Dyna Flex | Jun 5, 2023 | SESE |
| K222847 | Ceramic Brackets Orthometric | Orthometric - Industria E Comercio DE Produtos Medicos | May 4, 2023 | SESE |
| K222764 | LightForce Orthodontic System | Lightforce Orthodontics | Sep 14, 2022 | SESE |
| K220689 | Vatech Clismile | Rayence Co., Ltd. | May 6, 2022 | SESE |
| K201410 | VENUS Bracket, ROSE Bracket | Gni Co., Ltd. | Mar 12, 2021 | SESE |
| K201038 | Luce Ceramic Bracket | Luce Castle Co., Ltd. | Oct 9, 2020 | SESE |
| K200148 | LightForce Orthodontic System (LFO System) | Lightforce Orthodontics | Feb 21, 2020 | SESE |
| K182672 | ROSA Bracket | Gni Co., Ltd. | Nov 15, 2019 | SESE |
| K192202 | Clear21 | World Class Technology Corporation | Nov 12, 2019 | SESE |
| K190608 | Mei Ceramic Bracket | Orthosun Co., Ltd. | Nov 4, 2019 | SESE |
| K180952 | Ceramic Bracket | Mem Dental Technology Co., Ltd. | Jun 7, 2019 | SESE |
| K182193 | S-Line | Biocetec Co., Ltd. | Jan 22, 2019 | SESE |
| K183542 | Signature Orthodontic System | Signature Orthodontics | Jan 2, 2019 | SESE |
| K181271 | Signature Orthodontic System | Signature Orthodontics | Jun 13, 2018 | SESE |
| K180404 | 3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System | 3M Healthcare | Mar 16, 2018 | SESE |
| K173440 | Carriere SLX 3D Clear | Ortho Organizers, Inc. | Mar 8, 2018 | SESE |
| K172845 | Symetri Clear | Ormco Corporation | Jan 31, 2018 | SESE |
Top Applicants
- American Orthodontics — 3 clearances
- Biocetec Co., Ltd. — 3 clearances
- Cdb Corporation — 3 clearances
- Lightforce Orthodontics — 3 clearances
- Tomy, Inc. — 3 clearances
