Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart F — Therapeutic Devices](/submissions/DE/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 872.5470](/submissions/DE/subpart-f%E2%80%94therapeutic-devices/872.5470) → NJM — Bracket, Ceramic, Orthodontic # NJM · Bracket, Ceramic, Orthodontic _Dental · 21 CFR 872.5470 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/NJM ## Overview - **Product Code:** NJM - **Device Name:** Bracket, Ceramic, Orthodontic - **Regulation:** [21 CFR 872.5470](/submissions/DE/subpart-f%E2%80%94therapeutic-devices/872.5470) - **Device Class:** 2 - **Review Panel:** [Dental](/submissions/DE) - **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](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/NJM/K232827.md) | LightForce Orthodontic System | Lightforce Orthodontics | Sep 14, 2023 | SESE | | [K232011](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/NJM/K232011.md) | Cleo | American Orthodontics | Jul 7, 2023 | SESE | | [K231635](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/NJM/K231635.md) | A-Line Advanced | Biocetec Co., Ltd. | Jun 6, 2023 | SESE | | [K230225](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/NJM/K230225.md) | DynaFlex Clear Brackets & Buttons | Dyna Flex | Jun 5, 2023 | SESE | | [K222847](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/NJM/K222847.md) | Ceramic Brackets Orthometric | Orthometric - Industria E Comercio DE Produtos Medicos | May 4, 2023 | SESE | | [K222764](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/NJM/K222764.md) | LightForce Orthodontic System | Lightforce Orthodontics | Sep 14, 2022 | SESE | | [K220689](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/NJM/K220689.md) | Vatech Clismile | Rayence Co., Ltd. | May 6, 2022 | SESE | | [K201410](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/NJM/K201410.md) | VENUS Bracket, ROSE Bracket | Gni Co., Ltd. | Mar 12, 2021 | SESE | | [K201038](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/NJM/K201038.md) | Luce Ceramic Bracket | Luce Castle Co., Ltd. | Oct 9, 2020 | SESE | | [K200148](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/NJM/K200148.md) | LightForce Orthodontic System (LFO System) | Lightforce Orthodontics | Feb 21, 2020 | SESE | | [K182672](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/NJM/K182672.md) | ROSA Bracket | Gni Co., Ltd. | Nov 15, 2019 | SESE | | [K192202](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/NJM/K192202.md) | Clear21 | World Class Technology Corporation | Nov 12, 2019 | SESE | | [K190608](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/NJM/K190608.md) | Mei Ceramic Bracket | Orthosun Co., Ltd. | Nov 4, 2019 | SESE | | [K180952](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/NJM/K180952.md) | Ceramic Bracket | Mem Dental Technology Co., Ltd. | Jun 7, 2019 | SESE | | [K182193](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/NJM/K182193.md) | S-Line | Biocetec Co., Ltd. | Jan 22, 2019 | SESE | | [K183542](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/NJM/K183542.md) | Signature Orthodontic System | Signature Orthodontics | Jan 2, 2019 | SESE | | [K181271](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/NJM/K181271.md) | Signature Orthodontic System | Signature Orthodontics | Jun 13, 2018 | SESE | | [K180404](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/NJM/K180404.md) | 3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System | 3M Healthcare | Mar 16, 2018 | SESE | | [K173440](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/NJM/K173440.md) | Carriere SLX 3D Clear | Ortho Organizers, Inc. | Mar 8, 2018 | SESE | | [K172845](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/NJM/K172845.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/NJM](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/NJM) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com