DYH · Adhesive, Bracket And Tooth Conditioner, Resin
Dental · 21 CFR 872.3750 · Class 2
Overview
| Product Code | DYH |
|---|---|
| Device Name | Adhesive, Bracket And Tooth Conditioner, Resin |
| Regulation | 21 CFR 872.3750 |
| Device Class | Class 2 |
| Review Panel | Dental |
| 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 | Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree Adhesive | Ormco Corporation | Jan 3, 2025 | SESE |
| K242537 | BracePaste Fluoride Sealant | American Orthodontics Corp. | Aug 27, 2024 | SESE |
| K234043 | 3M Transbond Orthodontic Adhesive | 3M Unitek Orthodontic Products | Dec 22, 2023 | SESE |
| K231817 | AlignerFlow LC | Voco GmbH | Dec 1, 2023 | SESE |
| K214054 | TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520 | Tp Orthodontics, Inc. | Oct 14, 2022 | SESE |
| K210115 | FiteBac CC OrthoSeal | Largent Health, LLC | Jul 29, 2021 | SESE |
| K202276 | BracePaste Band and Build LC | American Orthodontics | Aug 14, 2020 | SESE |
| K192682 | Orthocem, Ortho Bite | Dentscare Ltda | Aug 14, 2020 | SESE |
| K193388 | GlassLok Kits, GlassLok Powder, GlassLok Liquid | Reliance Orthodontic Products, Inc. | Apr 27, 2020 | SESE |
| K183147 | BrackFix | Voco GmbH | Mar 1, 2019 | SESE |
| K173020 | OBA-MCP, Orthodontic Bracket Adhesive with MCP | Pulpdent Corporation | Jan 17, 2018 | SESE |
| K160782 | BracePaste Adhesive | American Orthodontics | Oct 14, 2016 | SESE |
| K161684 | Quantum LB | Reliance Orthodontic Products, Inc. | Oct 6, 2016 | SESE |
| K150128 | GC Ortho Connect, GC Ortho Etching Gel | Gc Orthodontics America, Inc. | Jul 16, 2015 | SESE |
| K143667 | GC KommonBase | Gc Orthodontics America, Inc. | May 7, 2015 | SESE |
| K142886 | DMRC Self-Cure Bracket Adhesive One Step and Primer | Danville Materials, LLC | Mar 18, 2015 | SESE |
| K142881 | DMRC Dual Cure Orthodontic Band Cement | Danville Materials, LLC | Feb 13, 2015 | SESE |
| K142880 | DMRC Light Cure Orthodontic Adhesive System | Daville Materials, LLC | Feb 4, 2015 | SESE |
| K123348 | CLEAR ALIGNER ADHESIVE | Reliance Orthodontic Products, Inc. | Feb 28, 2013 | SESE |
| K120619 | 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
