Dental Device Guide
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Therapeutic devices · 21 CFR 872 Subpart F

Orthodontic Plastic Bracket

FDA device type “Bracket, Plastic, Orthodontic”.

FDA codeDYWClass221 CFR872.5470Pathway510(k)CategoryOrthodontic brackets
Companies listing it
2618 makers
Brands and models
40
510(k) clearances
422 in five years
FDA name
Bracket, Plastic, Orthodontic
1978: 11980: 11986: 11987: 11989: 11990: 21993: 11994: 31995: 11996: 11997: 11998: 12003: 12004: 12005: 52006: 12007: 22008: 12009: 22010: 12011: 12012: 12013: 22014: 12016: 32018: 22020: 12025: 219801990200020102020

510(k) clearances per year, 1976–2026

Companies that list DYW

26 companies currently list this device type with FDA.

CompanyCountryRoleBrands and models listedClearancesLatest
GC America Inc.United StatesMakerEVERSTICK A&O1372026
Sybron Dental SpecialtiesUnited StatesMaker—2032026
Ultradent Products, Inc.United StatesMakerOpal Bond952026
American OrthodonticsUnited StatesMakerSilkon Plus™442026
Blue Sky Bio, LLCUnited StatesMakerBlue Sky Plan - IBT Module202024
Cdb CorporationUnited StatesMakerButtons92022
Ortho Organizers, Inc.United StatesMakerBite-Builder · Carriere Motion 3D Clear Class II Malocclusion · Carriere Motion Pro Clear Bite Corrector · Composite Direct Bond Button · +382025
EC Certification Service GmbHAustriaMakerClear · Clear Plus · ECC Premium Line · Larson Radius · +812025
Tomy, Inc.JapanMaker—42018
Gestenco International ABSwedenMakerSpringtime C · Vitrine12005
Sun Dental Laboratories, LLCUnited StatesMakerSunClear Aligner12019
Dentaurum GmbH & Co. KGGermanyMakerTranslucent Ideal Arch pearl——
Great Lakes Dental Technologies, Ltd.United StatesMakereXceed · Smart Moves Complete——
Solventum US LLCUnited StatesMakerClarity——
Modern OrthodonticsIndiaMakerCurio, Purity-MS, Purity,D'Art, Elegant——
EXCELDENT Dental Technology Development Co., Ltd.ChinaMakerSunClear Aligner——
Calibaja Manufacturing, S.A. de C.V.MexicoMaker———
MPL Manufacturing Inc.United StatesMaker———
Young Innovations IncUnited StatesContract manufacturerOrapro and Avair Brackets232025
Rmo, Inc.United StatesManufacturerAlice Composite, Alice Composite Roth, Alice Composite Edgewise system11990
Sawbros Industries Pvt., Ltd.IndiaManufacturerOrthodontic Ceramic Buttons12017
Ortho Arch Company IncUnited StatesRepacker / relabelerCOMPOSITE DIRECT BOND BUTTON——
Xplora USA LLCUnited StatesManufacturerSix Month Smiles——
KLOwen Braces dba KLOwen OrthodonticsUnited StatesManufacturerKLOwen Orthodontic Solution——
Northstar Trade Co., LimitedChinaForeign exporterSunClear Aligner——
Mainline Medical Dental SupplyCanadaForeign exporter———

510(k) clearances

Decided510(k)DeviceApplicant
27 Nov 2025K252760Carriere® Motion Pro® Clear Bite CorrectorOrtho Organizers, Inc.
21 Apr 2025K251196Composite Orthodontic Brackets and ButtonsEC Certification Service GmbH
3 Dec 2020K201940Braces on Demand BracketBraces on Demand, Inc.
9 Nov 2018K182338Blue Sky Bio Computerized Orthodontic Bracket SystemBlue Sky Bio, LLC
30 Oct 2018K180718ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIESTomy, Inc.
28 Nov 2016K160720Carriere Motion Clear Class IIOrtho Organizers, Inc.
26 Aug 2016K150830CompleClear Plastic Orthodontic Bracket and Wire ApplianceOracrew
24 Mar 2016K150702Exceed TxGreat Lakes Orthodontics, Ltd.
12 Nov 2014K140807COMPOSITE ORTHODONTIC BRACKETSOrtho Specialties
26 Mar 2013K123118INSIGNIA DIGICASTSybron Dental Specialties
13 Mar 2013K123416INSIGNIA WITH ITEROSybron Dental Specialties
9 Aug 2012K121524INSIGNIASybron Dental Specialties
31 Mar 2011K110796SIMPLICLEAR RECTANGULAR ORTHODONTIC WIREBiomers Products, LLC
13 Sep 2010K101676CLEARARCHSybron Dental Specialties
23 Oct 2009K082207ORTHOCAD IQCadent, Inc.
24 Jul 2009K092030ELATION MB METAL REINFORCED PLASTIC BRACKETDentsply Interntional
2 May 2008K081143BIOMERS TRANSLUCENT ORTHODONTIC WIREBiomers Product, LLC
3 May 2007K071055OPAL PRIME & OPAL BOND/ORTHODONTIC BRACKET SYSTEM, MODELS 2626, 2625, 2635, 2803, 2802Ultradent Products, Inc.
19 Jan 2007K061042LINGLOCKSybron Dental Specialties
21 Mar 2006K051953EVERSTICK A&OGC America Inc.
22 Dec 2005K053055ORTHODONTIC POLYMER COMPOSITE BRACKETGestenco International AB
30 Nov 2005K052477DAMON 3 MODIFIEDSybron Dental Specialties
1 Nov 2005K052370CP BRACKET SYSTEMDentsply International, Inc.
26 Oct 2005K052714RAVE COMPOSITE BRACKETFDA Agents
31 Mar 2005K050730MODIFICATION TO ORTHODONTIC COMPOSITE BRACKET SYSTEMUltradent Products, Inc.
26 Feb 2004K032625ORTHODONTIC COMPOSITE BRACKET SYSTEMUltradent Products, Inc.
15 Oct 2003K032408DAMON FTSybron Dental Specialties
25 Jun 1998K981433ORTHODONTIC BRACESMidwest Orthodontic Mfg.
21 Nov 1997K973776REFLECTIONSCdb Corporation
4 Jan 1996K955333SPIRIT MBSybron Dental Specialties
19 Jul 1995K951239GLOWING SPIRITSSybron Dental Specialties
14 Dec 1994K942826ORTHODONITC METAL REINFORCED PLASTIC BRACKETGac Intl., Inc.
29 Nov 1994K944286METAL-LINED TRANSCEND CERAMIC BRACKETUnitek Corp.
23 Aug 1994K943245SPIRIT MBSybron Dental Specialties
24 Aug 1993K932920GLENROE PLASTIC BRACKETGlenroe Technologies
28 Jun 1990K900809LEE-FISCHER CERAMIC REINFORCED PLASTIC BRACKETSLee Pharmaceuticals
8 Mar 1990K896913SPIRITSybron Dental Specialties
31 Mar 1989K891372ORTHODONTIC PLASTIC BRACKETAmerican Orthodontics
29 Dec 1987K874227PLASTIC BRACKETSAdvanced Orthodontics Systems, Inc.
9 Jun 1986K861965UNITEK CERAMIC BRACKET SYSTEMUnitek Corp.
19 Dec 1980K802899CERAMIBONDZulauf, Inc.
15 Mar 1978K780239BRACKET, METAL REINFORCED PLASTICSybron Dental Specialties

Official records: FDA product classification for DYW · 21 CFR 872.5470.

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026