FDA.report

510(k) K052477

Device
DAMON 3 MODIFIED
Applicant
Ormco Corp.
510(k) number
K052477
Product code
DYW
Decision
Substantially Equivalent (SESE)
Decision date
2005-11-30
Date received
2005-09-09
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

Related Records

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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