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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 K132368
FOIA Releasable 510(k) K132368
Device Name VAPOR CERAMIC BRACKET
Applicant
Orthodontic Design and Production, Inc.
1370 Decision St.
Suite D
Vista,  CA  92081
Applicant Contact RICHARD MERRELL
Correspondent
Orthodontic Design and Production, Inc.
1370 Decision St.
Suite D
Vista,  CA  92081
Correspondent Contact RICHARD MERRELL
Regulation Number872.5470
Classification Product Code
NJM  
Date Received07/30/2013
Decision Date 12/19/2013
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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