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/productcode/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 193)

Showing 20 most recent of 193 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K261840](/device/K261840.md) | BracePaste Prime Plus | American Orthodontics | Jun 3, 2026 | SESE |
| [K250015](/device/K250015.md) | Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree Adhesive | Ormco Corporation | Jan 3, 2025 | SESE |
| [K242537](/device/K242537.md) | BracePaste Fluoride Sealant | American Orthodontics Corp. | Aug 27, 2024 | SESE |
| [K234043](/device/K234043.md) | 3M™ Transbond™ Orthodontic Adhesive | 3M Unitek Orthodontic Products | Dec 22, 2023 | SESE |
| [K231817](/device/K231817.md) | AlignerFlow LC | Voco GmbH | Dec 1, 2023 | SESE |
| [K214054](/device/K214054.md) | TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520 | Tp Orthodontics, Inc. | Oct 14, 2022 | SESE |
| [K210115](/device/K210115.md) | FiteBac CC OrthoSeal | Largent Health, LLC | Jul 29, 2021 | SESE |
| [K202276](/device/K202276.md) | BracePaste Band and Build LC | American Orthodontics | Aug 14, 2020 | SESE |
| [K192682](/device/K192682.md) | Orthocem, Ortho Bite | Dentscare Ltda | Aug 14, 2020 | SESE |
| [K193388](/device/K193388.md) | GlassLok Kits, GlassLok Powder, GlassLok Liquid | Reliance Orthodontic Products, Inc. | Apr 27, 2020 | SESE |
| [K183147](/device/K183147.md) | BrackFix | Voco GmbH | Mar 1, 2019 | SESE |
| [K173020](/device/K173020.md) | OBA-MCP, Orthodontic Bracket Adhesive with MCP | Pulpdent Corporation | Jan 17, 2018 | SESE |
| [K160782](/device/K160782.md) | BracePaste Adhesive | American Orthodontics | Oct 14, 2016 | SESE |
| [K161684](/device/K161684.md) | Quantum LB | Reliance Orthodontic Products, Inc. | Oct 6, 2016 | SESE |
| [K150128](/device/K150128.md) | GC Ortho Connect, GC Ortho Etching Gel | Gc Orthodontics America, Inc. | Jul 16, 2015 | SESE |
| [K143667](/device/K143667.md) | GC KommonBase | Gc Orthodontics America, Inc. | May 7, 2015 | SESE |
| [K142886](/device/K142886.md) | DMRC Self-Cure Bracket Adhesive One Step and Primer | Danville Materials, LLC | Mar 18, 2015 | SESE |
| [K142881](/device/K142881.md) | DMRC Dual Cure Orthodontic Band Cement | Danville Materials, LLC | Feb 13, 2015 | SESE |
| [K142880](/device/K142880.md) | DMRC Light Cure Orthodontic Adhesive System | Daville Materials, LLC | Feb 4, 2015 | SESE |
| [K123348](/device/K123348.md) | CLEAR ALIGNER ADHESIVE | Reliance Orthodontic Products, Inc. | Feb 28, 2013 | SESE |

## Top Applicants

- Reliance Orthodontic Products, Inc. — 23 clearances
- Sybron Dental Specialties, Inc. — 12 clearances
- Ormco Corp. — 9 clearances
- American Orthodontics — 7 clearances
- Dentsply Intl. — 7 clearances

---

**Source:** [https://fda.innolitics.com/productcode/DYH](https://fda.innolitics.com/productcode/DYH)

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