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 Number	872.3260
Classification Product Code	PHR
Subsequent Product Code	LBH
Date Received	07/06/2017
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