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510(k) K053055

Device
ORTHODONTIC POLYMER COMPOSITE BRACKET
Applicant
GESTENCO INTERNATIONAL AB
510(k) number
K053055
Product code
DYW  
Decision
Substantially Equivalent (SESE)
Decision date
2005-12-22
Date received
2005-10-31
Regulation
872.5470
Classification name
Bracket, Plastic, Orthodontic
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
GORAN STEEN
Address
14 Fridkullagatan Goteborg SE SE 400 22 SE 400 22

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
K251196Composite Orthodontic Brackets and ButtonsEc Certification Service GmbH2025-04-21
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

Legacy Summary#

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FDA Review#

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