510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K172047Substantially Equivalent

Riva Star

Sdi Ltd., Bayswater, AU / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K172047 is the FDA 510(k) clearance record for Riva Star, a class II device, cleared for Sdi Limited on under FDA product code PHR (Diammine Silver Fluoride Dental Hypersensitivity Varnish). FDA's definition for product code PHR reads: "Applied to tooth enamel to block dentinal tubules for the purpose of reducing tooth sensitivity". FDA records list 4 510(k) clearances for Sdi Limited, from to . As of , FDA records show no recalls naming K172047.

Clearance record

Decision date
Received
(279 days to decision)
Product code
PHR Diammine Silver Fluoride Dental Hypersensitivity Varnish
Regulation
21 CFR 872.3260
Device class
Class II
Review panel
Dental
Applicant
Sdi Limited 3-13 Brunsdon St., Bayswater, AU
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PHR

Trailing 12 months

FDA records hold no clearances under product code PHR in the trailing twelve months.

FDA records show no clearances under product code PHR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PHR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260