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) → DYW — Bracket, Plastic, Orthodontic # DYW · Bracket, Plastic, Orthodontic _Dental · 21 CFR 872.5470 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DYW ## Overview - **Product Code:** DYW - **Device Name:** Bracket, Plastic, 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 42) Showing 20 most recent of 42 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K252760](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DYW/K252760.md) | Carriere® Motion Pro® Clear Bite Corrector | Ortho Organizers, Inc. | Nov 27, 2025 | SESE | | [K251196](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DYW/K251196.md) | Composite Orthodontic Brackets and Buttons | Ec Certification Service GmbH | Apr 21, 2025 | SESE | | [K201940](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DYW/K201940.md) | Braces on Demand Bracket | Braces on Demand, Inc. | Dec 3, 2020 | SESE | | [K182338](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DYW/K182338.md) | Blue Sky Bio Computerized Orthodontic Bracket System | Blue Sky Bio | Nov 9, 2018 | SESE | | [K180718](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DYW/K180718.md) | ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES | Tomy, Inc. | Oct 30, 2018 | SESE | | [K160720](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DYW/K160720.md) | Carriere Motion Clear Class II | Ortho Organizers, Inc. | Nov 28, 2016 | SESE | | [K150830](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DYW/K150830.md) | CompleClear Plastic Orthodontic Bracket and Wire Appliance | Oracrew | Aug 26, 2016 | SESE | | [K150702](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DYW/K150702.md) | Exceed Tx | Great Lakes Orthodontics, Ltd. | Mar 24, 2016 | SESE | | [K140807](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DYW/K140807.md) | COMPOSITE ORTHODONTIC BRACKETS | Ortho Specialties | Nov 12, 2014 | SESE | | [K123118](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DYW/K123118.md) | INSIGNIA DIGICAST | Ormco Corp. | Mar 26, 2013 | SESE | | [K123416](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DYW/K123416.md) | INSIGNIA WITH ITERO | Ormco Corp. | Mar 13, 2013 | SESE | | [K121524](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DYW/K121524.md) | INSIGNIA | Ormco Corp. | Aug 9, 2012 | SESE | | [K110796](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DYW/K110796.md) | SIMPLICLEAR RECTANGULAR ORTHODONTIC WIRE | Biomers Products, LLC | Mar 31, 2011 | SESE | | [K101676](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DYW/K101676.md) | CLEARARCH | Ormco Corp. | Sep 13, 2010 | SESE | | [K082207](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DYW/K082207.md) | ORTHOCAD IQ | Cadent, Inc. | Oct 23, 2009 | SESE | | [K092030](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DYW/K092030.md) | ELATION MB METAL REINFORCED PLASTIC BRACKET | Dentsply Interntional | Jul 24, 2009 | SESE | | [K081143](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DYW/K081143.md) | BIOMERS TRANSLUCENT ORTHODONTIC WIRE | Biomers Product, LLC | May 2, 2008 | SESE | | [K071055](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DYW/K071055.md) | OPAL PRIME & OPAL BOND/ORTHODONTIC BRACKET SYSTEM, MODELS 2626, 2625, 2635, 2803, 2802 | Ultradent Products, Inc. | May 3, 2007 | SESE | | [K061042](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DYW/K061042.md) | LINGLOCK | Sybron Dental Specialties | Jan 19, 2007 | SESE | | [K051953](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DYW/K051953.md) | EVERSTICK A&O | Stick Tech , Ltd. | Mar 21, 2006 | SESE | ## Top Applicants - Ormco Corp. — 9 clearances - Ultradent Products, Inc. — 3 clearances - Ortho Organizers, Inc. — 2 clearances - Sybron Dental Specialties, Inc. — 2 clearances - Unitek Corp. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DYW](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DYW) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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