DYW · Class II · 21 CFR 872.5470

FDA Product Code DYW: Bracket, Plastic, Orthodontic

Leading manufacturers include Ormco Corp., Ultradent Products, Inc. and Ortho Organizers, Inc..

42
Total
42
Cleared
118d
Avg days
1978
Since
Growing category - 2 submissions in the last 2 years vs 0 in the prior period
Review times improving: avg 47d recently vs 121d historically

FDA 510(k) Cleared Bracket, Plastic, Orthodontic Devices (Product Code DYW)

42 devices
1–24 of 42
Cleared Nov 27, 2025
Carriere® Motion Pro® Clear Bite Corrector
K252760
Ortho Organizers, Inc.
Dental · 90d
Cleared Apr 21, 2025
Composite Orthodontic Brackets and Buttons
K251196
Ec Certification Service GmbH
Dental · 4d
Cleared Dec 03, 2020
Braces on Demand Bracket
K201940
Braces on Demand, Inc.
Dental · 143d
Cleared Nov 09, 2018
Blue Sky Bio Computerized Orthodontic Bracket System
K182338
Blue Sky Bio
Dental · 73d
Cleared Oct 30, 2018
ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES
K180718
Tomy, Inc.
Dental · 225d
Cleared Nov 28, 2016
Carriere Motion Clear Class II
K160720
Ortho Organizers, Inc.
Dental · 257d
Cleared Aug 26, 2016
CompleClear Plastic Orthodontic Bracket and Wire Appliance
K150830
Oracrew
Dental · 515d
Cleared Mar 24, 2016
Exceed Tx
K150702
Great Lakes Orthodontics, Ltd.
Dental · 372d
Cleared Nov 12, 2014
COMPOSITE ORTHODONTIC BRACKETS
K140807
Ortho Specialties
Dental · 225d
Cleared Mar 26, 2013
INSIGNIA DIGICAST
K123118
Ormco Corp.
Dental · 174d
Cleared Mar 13, 2013
INSIGNIA WITH ITERO
K123416
Ormco Corp.
Dental · 127d
Cleared Aug 09, 2012
INSIGNIA
K121524
Ormco Corp.
Dental · 78d
Cleared Mar 31, 2011
SIMPLICLEAR RECTANGULAR ORTHODONTIC WIRE
K110796
Biomers Products, LLC
Dental · 9d
Cleared Sep 13, 2010
CLEARARCH
K101676
Ormco Corp.
Dental · 90d
Cleared Oct 23, 2009
ORTHOCAD IQ
K082207
Cadent, Inc.
Dental · 444d
Cleared Jul 24, 2009
ELATION MB METAL REINFORCED PLASTIC BRACKET
K092030
Dentsply Interntional
Dental · 18d
Cleared May 02, 2008
BIOMERS TRANSLUCENT ORTHODONTIC WIRE
K081143
Biomers Product, LLC
Dental · 10d
Cleared May 03, 2007
OPAL PRIME & OPAL BOND/ORTHODONTIC BRACKET SYSTEM, MODELS 2626, 2625, 2635, 2803, 2802
K071055
Ultradent Products, Inc.
Dental · 17d
Cleared Jan 19, 2007
LINGLOCK
K061042
Sybron Dental Specialties
Dental · 280d
Cleared Mar 21, 2006
EVERSTICK A&O
K051953
Stick Tech , Ltd.
Dental · 246d
Cleared Dec 22, 2005
ORTHODONTIC POLYMER COMPOSITE BRACKET
K053055
Gestenco International AB
Dental · 52d
Cleared Nov 30, 2005
DAMON 3 MODIFIED
K052477
Ormco Corp.
Dental · 82d
Cleared Nov 01, 2005
CP BRACKET SYSTEM
K052370
Dentsply International
Dental · 63d
Cleared Oct 26, 2005
RAVE COMPOSITE BRACKET
K052714
FDA Agents
Dental · 27d

About Product Code DYW - Regulatory Context

510(k) Submission Activity

42 total 510(k) submissions under product code DYW since 1978, with 42 receiving FDA clearance (average review time: 118 days).

Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - DYW Product Code

Recent submissions under DYW have taken an average of 47 days to reach a decision - down from 121 days historically, suggesting improved FDA processing for this classification.

DYW devices are reviewed by the Dental panel. Browse all Dental devices →