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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bracket, Plastic, Orthodontic
510(k) Number K032408
Device Name DAMON FT
Applicant
SYBRON DENTAL SPECIALTIES, INC.
1717 W. COLLINS AVE.
ORANGE,  CA  92867
Applicant Contact COLLEEN BOSWELL
Correspondent
SYBRON DENTAL SPECIALTIES, INC.
1717 W. COLLINS AVE.
ORANGE,  CA  92867
Correspondent Contact COLLEEN BOSWELL
Regulation Number872.5470
Classification Product Code
DYW  
Date Received08/04/2003
Decision Date 10/15/2003
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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