FDA.reportPublic FDA data

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

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#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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