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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 K142729
Device Name Chi Lites Orthodontic Sapphire Bracket
Applicant
PROGRESSIVE TECHNOLOGY, INC.
4130 CITRUS AVE #17
ROCKLIN,  CA  95677
Applicant Contact Shannon Rogers
Correspondent
PROGRESSIVE TECHNOLOGY, INC.
4130 CITRUS AVE #17
ROCKLIN,  CA  95677
Correspondent Contact Shannon Rogers
Regulation Number872.5470
Classification Product Code
NJM  
Date Received09/23/2014
Decision Date 05/15/2015
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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