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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diammine Silver Fluoride Dental Hypersensitivity Varnish
510(k) Number K172047
Device Name Riva Star
Applicant
SDI Limited
3-13 Brunsdon Street
Bayswater,  AU 3153
Applicant Contact Ray Cahill
Correspondent
SDI Limited
3-13 Brunsdon Street
Bayswater,  AU 3153
Correspondent Contact Ray Cahill
Regulation Number872.3260
Classification Product Code
PHR  
Subsequent Product Code
LBH  
Date Received07/06/2017
Decision Date 04/11/2018
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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