DYW · Bracket, Plastic, Orthodontic
Dental · 21 CFR 872.5470 · Class 2
Overview
| Product Code | DYW |
|---|---|
| Device Name | Bracket, Plastic, Orthodontic |
| Regulation | 21 CFR 872.5470 |
| Device Class | Class 2 |
| Review Panel | Dental |
| 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 | Carriere® Motion Pro® Clear Bite Corrector | Ortho Organizers, Inc. | Nov 27, 2025 | SESE |
| K251196 | Composite Orthodontic Brackets and Buttons | Ec Certification Service GmbH | Apr 21, 2025 | SESE |
| K201940 | Braces on Demand Bracket | Braces on Demand, Inc. | Dec 3, 2020 | SESE |
| K182338 | Blue Sky Bio Computerized Orthodontic Bracket System | Blue Sky Bio | Nov 9, 2018 | SESE |
| K180718 | ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES | Tomy, Inc. | Oct 30, 2018 | SESE |
| K160720 | Carriere Motion Clear Class II | Ortho Organizers, Inc. | Nov 28, 2016 | SESE |
| K150830 | CompleClear Plastic Orthodontic Bracket and Wire Appliance | Oracrew | Aug 26, 2016 | SESE |
| K150702 | Exceed Tx | Great Lakes Orthodontics, Ltd. | Mar 24, 2016 | SESE |
| K140807 | COMPOSITE ORTHODONTIC BRACKETS | Ortho Specialties | Nov 12, 2014 | SESE |
| K123118 | INSIGNIA DIGICAST | Ormco Corp. | Mar 26, 2013 | SESE |
| K123416 | INSIGNIA WITH ITERO | Ormco Corp. | Mar 13, 2013 | SESE |
| K121524 | INSIGNIA | Ormco Corp. | Aug 9, 2012 | SESE |
| K110796 | SIMPLICLEAR RECTANGULAR ORTHODONTIC WIRE | Biomers Products, LLC | Mar 31, 2011 | SESE |
| K101676 | CLEARARCH | Ormco Corp. | Sep 13, 2010 | SESE |
| K082207 | ORTHOCAD IQ | Cadent, Inc. | Oct 23, 2009 | SESE |
| K092030 | ELATION MB METAL REINFORCED PLASTIC BRACKET | Dentsply Interntional | Jul 24, 2009 | SESE |
| K081143 | BIOMERS TRANSLUCENT ORTHODONTIC WIRE | Biomers Product, LLC | May 2, 2008 | SESE |
| K071055 | OPAL PRIME & OPAL BOND/ORTHODONTIC BRACKET SYSTEM, MODELS 2626, 2625, 2635, 2803, 2802 | Ultradent Products, Inc. | May 3, 2007 | SESE |
| K061042 | LINGLOCK | Sybron Dental Specialties | Jan 19, 2007 | SESE |
| K051953 | EVERSTICK A&O | Stick Tech , Ltd. | Mar 21, 2006 | SESE |
Top Applicants
- Ormco Corp. — 9 clearances
- Ultradent Products, Inc. — 3 clearances
- Unitek Corp. — 2 clearances
- Sybron Dental Specialties, Inc. — 2 clearances
- Ortho Organizers, Inc. — 2 clearances
