DYWClass II

Bracket, Plastic, Orthodontic

21 CFR 872.5470 / Dental

DYW is the FDA product code for Bracket, Plastic, Orthodontic, a class II device type, regulated under 21 CFR 872.5470. As of 2026-09-10, FDA records hold 42 510(k) clearances under this code, the most recent dated 2025-11-27, and 5 recalls.

Classification record

Product code: DYW
Device name: Bracket, Plastic, Orthodontic
Regulation: 21 CFR 872.5470
Device class: Class II
Review panel: Dental
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 42
Ingested recalls: 5

Clearances, product code DYW

By decision year

42 clearances under product code DYW with a decision year between 1978 and 2025, 2005 the highest year at 5.

Show the numbers

510(k) clearances under FDA product code DYW by decision year
Year	Clearances
1978	1
1980	1
1986	1
1987	1
1989	1
1990	2
1993	1
1994	3
1995	1
1996	1
1997	1
1998	1
2003	1
2004	1
2005	5
2006	1
2007	2
2008	1
2009	2
2010	1
2011	1
2012	1
2013	2
2014	1
2016	3
2018	2
2020	1
2025	2

Applicants with the most clearances

Product code DYW

Applicants holding the most 510(k) clearances under product code DYW
Applicant	Clearances
Ormco Corp.	5
Ormco Corp.	3
Sybron Dental Specialties, Inc.	3
Ultradent Products Inc.	3
Ortho Organizers Inc	2
Unitek Corp.	2
Advanced Orthodontics Systems, Inc.	1
American Orthodontics	1
Biomers Product, LLC	1
Biomers Products, LLC	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 29 companies shown, in name order