Home / Device Classification / DYW

DYW — Bracket, Plastic, Orthodontic Class II

FDA Device Classification

FDA product code DYW covers "Bracket, Plastic, Orthodontic", a Class II medical device regulated under 21 CFR 872.5470. Submissions are reviewed by the Dental panel. At least 20 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
DYW
Device Class
Class II
Regulation Number
872.5470
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K252760ortho organizersCarriere® Motion Pro® Clear Bite CorrectorNovember 27, 2025
K251196ec certification serviceComposite Orthodontic Brackets and ButtonsApril 21, 2025
K201940braces on demandBraces on Demand BracketDecember 3, 2020
K182338blue sky bioBlue Sky Bio Computerized Orthodontic Bracket SystemNovember 9, 2018
K180718tomyORTHODONTIC PLASTIC BRACKETS AND ACCESSORIESOctober 30, 2018
K160720ortho organizersCarriere Motion Clear Class IINovember 28, 2016
K150830oracrewCompleClear Plastic Orthodontic Bracket and Wire ApplianceAugust 26, 2016
K150702great lakes orthodonticsExceed TxMarch 24, 2016
K140807ortho specialtiesCOMPOSITE ORTHODONTIC BRACKETSNovember 12, 2014
K123118ormcoINSIGNIA DIGICASTMarch 26, 2013
K123416ormcoINSIGNIA WITH ITEROMarch 13, 2013
K121524ormcoINSIGNIAAugust 9, 2012
K110796biomers productsSIMPLICLEAR RECTANGULAR ORTHODONTIC WIREMarch 31, 2011
K101676ormcoCLEARARCHSeptember 13, 2010
K082207cadentORTHOCAD IQOctober 23, 2009
K092030dentsply interntionalELATION MB METAL REINFORCED PLASTIC BRACKETJuly 24, 2009
K081143biomers productBIOMERS TRANSLUCENT ORTHODONTIC WIREMay 2, 2008
K071055ultradent productsOPAL PRIME & OPAL BOND/ORTHODONTIC BRACKET SYSTEM, MODELS 2626, 2625, 2635, 2803May 3, 2007
K061042sybron dental specialtiesLINGLOCKJanuary 19, 2007
K051953stick techEVERSTICK A&OMarch 21, 2006

FDA data resources