Cleared Traditional

Riva Star

K172047 · Sdi Limited · Dental
Apr 2018
Decision
279d
Days
Class 2
Risk

About This 510(k) Submission

K172047 is an FDA 510(k) clearance for the Riva Star, a Diammine Silver Fluoride Dental Hypersensitivity Varnish (Class II — Special Controls, product code PHR), submitted by Sdi Limited (Bayswater, AU). The FDA issued a Cleared decision on April 11, 2018, 279 days after receiving the submission on July 6, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.3260.

Submission Details

510(k) Number K172047 FDA.gov
FDA Decision Cleared SESE
Date Received July 06, 2017
Decision Date April 11, 2018
Days to Decision 279 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code PHR — Diammine Silver Fluoride Dental Hypersensitivity Varnish
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3260
Definition Applied To Tooth Enamel To Block Dentinal Tubules For The Purpose Of Reducing Tooth Sensitivity.