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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 K130446
FOIA Releasable 510(k) K130446
Device Name FASTBRACES CERAMIC BRACKETS
Applicant
ORTHODONTIC DESIGN AND PRODUCTION, INC.
1370 DECISION STREET
SUITE D
VISTA,  CA  92081
Applicant Contact RICHARD MERRELL
Correspondent
ORTHODONTIC DESIGN AND PRODUCTION, INC.
1370 DECISION STREET
SUITE D
VISTA,  CA  92081
Correspondent Contact RICHARD MERRELL
Regulation Number872.5470
Classification Product Code
NJM  
Date Received02/21/2013
Decision Date 06/07/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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