FDA.report

510(k) K251196

Device
Composite Orthodontic Brackets and Buttons
Applicant
Ec Certification Service GmbH
510(k) number
K251196
Product code
DYW
Decision
Substantially Equivalent (SESE)
Decision date
2025-04-21
Date received
2025-04-17
Regulation
872.5470
Classification name
Bracket, Plastic, Orthodontic
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
Y

Related Records

Applicant Contact

Contact
Elisabeth Moschik
Address
Sandgasse 39a Sankt Veit An Der Glan AT 9300 9300

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code DYW

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K252760Carriere® Motion Pro® Clear Bite CorrectorOrtho Organizers, Inc.2025-11-27
K201940Braces on Demand BracketBraces on Demand, Inc.2020-12-03
K182338Blue Sky Bio Computerized Orthodontic Bracket SystemBlue Sky Bio2018-11-09
K180718ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIESTomy, Inc.2018-10-30
K160720Carriere Motion Clear Class IIOrtho Organizers, Inc.2016-11-28
K150830CompleClear Plastic Orthodontic Bracket and Wire ApplianceOracrew2016-08-26
K150702Exceed TxGreat Lakes Orthodontics, Ltd.2016-03-24
K140807COMPOSITE ORTHODONTIC BRACKETSOrtho Specialties2014-11-12
K123118INSIGNIA DIGICASTOrmco Corp.2013-03-26
K123416INSIGNIA WITH ITEROOrmco Corp.2013-03-13
K121524INSIGNIAOrmco Corp.2012-08-09
K110796SIMPLICLEAR RECTANGULAR ORTHODONTIC WIREBiomers Products, LLC2011-03-31
K101676CLEARARCHOrmco Corp.2010-09-13
K082207ORTHOCAD IQCadent, Inc.2009-10-23
K092030ELATION MB METAL REINFORCED PLASTIC BRACKETDentsply Interntional2009-07-24