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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
SDI Limited
3-13 Brunsdon Street
Bayswater,  AU 3153
Applicant Contact Ray Cahill
SDI Limited
3-13 Brunsdon Street
Bayswater,  AU 3153
Correspondent Contact Ray Cahill
Regulation Number872.3260
Classification Product Code
Subsequent Product Code
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