FDA.reportPublic FDA data

510(k) K032408

Device
DAMON FT
Applicant
Sybron Dental Specialties, Inc.
510(k) number
K032408
Product code
DYW
Decision
Substantially Equivalent (SESE)
Decision date
2003-10-15
Date received
2003-08-04
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
N

Applicant Contact#

Contact
COLLEEN BOSWELL
Address
1717 W. Collins Ave. Orange CA US 92867 92867

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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K123118INSIGNIA DIGICASTOrmco Corp.2013-03-26
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K110796SIMPLICLEAR RECTANGULAR ORTHODONTIC WIREBiomers Products, LLC2011-03-31
K101676CLEARARCHOrmco Corp.2010-09-13
K082207ORTHOCAD IQCadent, Inc.2009-10-23