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