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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bracket, Ceramic, Orthodontic
510(k) Number K081415
Device Name DAMON 4CLEAR
Applicant
Ormco Corp.
1717 W. Collins Ave.
Orange,  CA  92867
Applicant Contact Wendy Garman
Correspondent
Ormco Corp.
1717 W. Collins Ave.
Orange,  CA  92867
Correspondent Contact Wendy Garman
Regulation Number872.5470
Classification Product Code
NJM  
Date Received05/20/2008
Decision Date 09/24/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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