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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 K110335
FOIA Releasable 510(k) K110335
Device Name CERAMIC BRACKETS
Applicant
Ortho Organizers, Inc.
1822 Aston Ave.
Carlsbad,  CA  92008 -7603
Applicant Contact FOSTER BOOP
Correspondent
Ortho Organizers, Inc.
1822 Aston Ave.
Carlsbad,  CA  92008 -7603
Correspondent Contact FOSTER BOOP
Regulation Number872.5470
Classification Product Code
NJM  
Date Received02/04/2011
Decision Date 05/19/2011
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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