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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 K131197
FOIA Releasable 510(k) K131197
Device Name EDGEWISE CERAMIC BRACKETS, ROTH CERAMIC BRACKETS
Applicant
DENTAL MORELLI
18851 NE 29TH AVE 720
AVENTURA,  FL  33180
Applicant Contact TARA CONRAD
Correspondent
DENTAL MORELLI
18851 NE 29TH AVE 720
AVENTURA,  FL  33180
Correspondent Contact TARA CONRAD
Regulation Number872.5470
Classification Product Code
NJM  
Date Received04/26/2013
Decision Date 08/27/2013
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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