Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3750](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3750) → DYH — Adhesive, Bracket And Tooth Conditioner, Resin # DYH · Adhesive, Bracket And Tooth Conditioner, Resin _Dental · 21 CFR 872.3750 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DYH ## Overview - **Product Code:** DYH - **Device Name:** Adhesive, Bracket And Tooth Conditioner, Resin - **Regulation:** [21 CFR 872.3750](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3750) - **Device Class:** 2 - **Review Panel:** [Dental](/submissions/DE) - **3rd-party reviewable:** yes ## Identification A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface. ## Classification Rationale Class II. ## Recent Cleared Devices (20 of 192) Showing 20 most recent of 192 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K250015](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DYH/K250015.md) | Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree Adhesive | Ormco Corporation | Jan 3, 2025 | SESE | | [K242537](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DYH/K242537.md) | BracePaste Fluoride Sealant | American Orthodontics Corp. | Aug 27, 2024 | SESE | | [K234043](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DYH/K234043.md) | 3M™ Transbond™ Orthodontic Adhesive | 3M Unitek Orthodontic Products | Dec 22, 2023 | SESE | | [K231817](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DYH/K231817.md) | AlignerFlow LC | Voco GmbH | Dec 1, 2023 | SESE | | [K214054](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DYH/K214054.md) | TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520 | Tp Orthodontics, Inc. | Oct 14, 2022 | SESE | | [K210115](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DYH/K210115.md) | FiteBac CC OrthoSeal | Largent Health, LLC | Jul 29, 2021 | SESE | | [K202276](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DYH/K202276.md) | BracePaste Band and Build LC | American Orthodontics | Aug 14, 2020 | SESE | | [K192682](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DYH/K192682.md) | Orthocem, Ortho Bite | Dentscare Ltda | Aug 14, 2020 | SESE | | [K193388](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DYH/K193388.md) | GlassLok Kits, GlassLok Powder, GlassLok Liquid | Reliance Orthodontic Products, Inc. | Apr 27, 2020 | SESE | | [K183147](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DYH/K183147.md) | BrackFix | Voco GmbH | Mar 1, 2019 | SESE | | [K173020](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DYH/K173020.md) | OBA-MCP, Orthodontic Bracket Adhesive with MCP | Pulpdent Corporation | Jan 17, 2018 | SESE | | [K160782](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DYH/K160782.md) | BracePaste Adhesive | American Orthodontics | Oct 14, 2016 | SESE | | [K161684](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DYH/K161684.md) | Quantum LB | Reliance Orthodontic Products, Inc. | Oct 6, 2016 | SESE | | [K150128](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DYH/K150128.md) | GC Ortho Connect, GC Ortho Etching Gel | Gc Orthodontics America, Inc. | Jul 16, 2015 | SESE | | [K143667](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DYH/K143667.md) | GC KommonBase | Gc Orthodontics America, Inc. | May 7, 2015 | SESE | | [K142886](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DYH/K142886.md) | DMRC Self-Cure Bracket Adhesive One Step and Primer | Danville Materials, LLC | Mar 18, 2015 | SESE | | [K142881](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DYH/K142881.md) | DMRC Dual Cure Orthodontic Band Cement | Danville Materials, LLC | Feb 13, 2015 | SESE | | [K142880](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DYH/K142880.md) | DMRC Light Cure Orthodontic Adhesive System | Daville Materials, LLC | Feb 4, 2015 | SESE | | [K123348](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DYH/K123348.md) | CLEAR ALIGNER ADHESIVE | Reliance Orthodontic Products, Inc. | Feb 28, 2013 | SESE | | [K120619](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DYH/K120619.md) | ORTHODONTIC FLOWABLE BRACKET ADHESIVE | Novocol, Inc. | May 21, 2012 | SESE | ## Top Applicants - Reliance Orthodontic Products, Inc. — 23 clearances - Sybron Dental Specialties, Inc. — 12 clearances - Ormco Corp. — 9 clearances - Scientific Pharmaceuticals, Inc. — 7 clearances - Pulpdent Corp. — 7 clearances --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DYH](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DYH) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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