Product Code: DYW FDA class 2 21 CFR 872.5470

Bracket, Plastic, Orthodontic

Dental

The Plastic Orthodontic Bracket is a dental device made from a polymeric material that is bonded to tooth surfaces and used to attach arch wires during orthodontic treatment to apply controlled forces that move teeth into the desired position. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) clearance before marketing. The product code is DYW and the applicable regulation is 21 CFR 872.5470, under the Dental medical specialty. This device is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: DYW
Device Class: FDA class 2
Regulation Number: 872.5470
Medical Specialty: Dental
Review Panel: DE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 42 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K252760	Carriere® Motion Pro® Clear Bite Corrector	Nov 27, 2025	Substantially Equivalent	Ortho Organizers, Inc.
K251196	Composite Orthodontic Brackets and Buttons	Apr 21, 2025	Substantially Equivalent	Ec Certification Service GmbH
K201940	Braces on Demand Bracket	Dec 03, 2020	Substantially Equivalent	Braces on Demand, Inc.
K182338	Blue Sky Bio Computerized Orthodontic Bracket System	Nov 09, 2018	Substantially Equivalent	Blue Sky Bio
K180718	ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES	Oct 30, 2018	Substantially Equivalent	Tomy, Inc.
K160720	Carriere Motion Clear Class II	Nov 28, 2016	Substantially Equivalent	Ortho Organizers, Inc.
K150830	CompleClear Plastic Orthodontic Bracket and Wire Appliance	Aug 26, 2016	Substantially Equivalent	Oracrew
K150702	Exceed Tx	Mar 24, 2016	Substantially Equivalent	Great Lakes Orthodontics, Ltd.
K140807	COMPOSITE ORTHODONTIC BRACKETS	Nov 12, 2014	Substantially Equivalent	Ortho Specialties
K123118	INSIGNIA DIGICAST	Mar 26, 2013	Substantially Equivalent	Ormco Corp.
K123416	INSIGNIA WITH ITERO	Mar 13, 2013	Substantially Equivalent	Ormco Corp.
K121524	INSIGNIA	Aug 09, 2012	Substantially Equivalent	Ormco Corp.
K110796	SIMPLICLEAR RECTANGULAR ORTHODONTIC WIRE	Mar 31, 2011	Substantially Equivalent	Biomers Products, LLC
K101676	CLEARARCH	Sep 13, 2010	Substantially Equivalent	Ormco Corp.
K082207	ORTHOCAD IQ	Oct 23, 2009	Substantially Equivalent	Cadent, Inc.
K092030	ELATION MB METAL REINFORCED PLASTIC BRACKET	Jul 24, 2009	Substantially Equivalent	Dentsply Interntional
K081143	BIOMERS TRANSLUCENT ORTHODONTIC WIRE	May 02, 2008	Substantially Equivalent	Biomers Product, LLC
K071055	OPAL PRIME & OPAL BOND/ORTHODONTIC BRACKET SYSTEM, MODELS 2626, 2625, 2635, 2803, 2802	May 03, 2007	Substantially Equivalent	Ultradent Products, Inc.
K061042	LINGLOCK	Jan 19, 2007	Substantially Equivalent	Sybron Dental Specialties
K051953	EVERSTICK A&O	Mar 21, 2006	Substantially Equivalent	Stick Tech , Ltd.
K053055	ORTHODONTIC POLYMER COMPOSITE BRACKET	Dec 22, 2005	Substantially Equivalent	Gestenco International AB
K052477	DAMON 3 MODIFIED	Nov 30, 2005	Substantially Equivalent	Ormco Corp.
K052370	CP BRACKET SYSTEM	Nov 01, 2005	Substantially Equivalent	Dentsply International
K052714	RAVE COMPOSITE BRACKET	Oct 26, 2005	Substantially Equivalent	FDA Agents
K050730	MODIFICATION TO ORTHODONTIC COMPOSITE BRACKET SYSTEM	Mar 31, 2005	Substantially Equivalent	Ultradent Products, Inc.
K032625	ORTHODONTIC COMPOSITE BRACKET SYSTEM	Feb 26, 2004	Substantially Equivalent	Ultradent Products, Inc.
K032408	DAMON FT	Oct 15, 2003	Substantially Equivalent	Sybron Dental Specialties, Inc.
K981433	ORTHODONTIC BRACES	Jun 25, 1998	Substantially Equivalent	Midwest Orthodontic Mfg.
K973776	REFLECTIONS	Nov 21, 1997	Substantially Equivalent	Cdb Corp.
K955333	SPIRIT MB	Jan 04, 1996	Substantially Equivalent	Ormco Corp.
K951239	GLOWING SPIRITS	Jul 19, 1995	Substantially Equivalent	Ormco Corp.
K942826	ORTHODONITC METAL REINFORCED PLASTIC BRACKET	Dec 14, 1994	Substantially Equivalent	Gac Intl., Inc.
K944286	METAL-LINED TRANSCEND CERAMIC BRACKET	Nov 29, 1994	Substantially Equivalent	Unitek Corp.
K943245	SPIRIT MB	Aug 23, 1994	Substantially Equivalent	Sybron Dental Specialties, Inc.
K932920	GLENROE PLASTIC BRACKET	Aug 24, 1993	Substantially Equivalent	Glenroe Technologies
K900809	LEE-FISCHER CERAMIC REINFORCED PLASTIC BRACKETS	Jun 28, 1990	Substantially Equivalent	Lee Pharmaceuticals
K896913	SPIRIT	Mar 08, 1990	Substantially Equivalent	Ormco Corp.
K891372	ORTHODONTIC PLASTIC BRACKET	Mar 31, 1989	Substantially Equivalent	American Orthodontics
K874227	PLASTIC BRACKETS	Dec 29, 1987	Substantially Equivalent	Advanced Orthodontics Systems, Inc.
K861965	UNITEK CERAMIC BRACKET SYSTEM	Jun 09, 1986	Substantially Equivalent	Unitek Corp.
K802899	CERAMIBOND	Dec 19, 1980	Substantially Equivalent	Zulauf, Inc.
K780239	BRACKET, METAL REINFORCED PLASTIC	Mar 15, 1978	Substantially Equivalent	Ormco Corp.