Riva Star
K-Number: K172047 · 2018-04-11
ApplicantSdi Limited
Decision Date2018-04-11
Product CodePHR
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Riva Star is a medical device manufactured by Sdi Limited. It received FDA 510(k) clearance on 2018-04-11 under approval number K172047. The device is classified under product code PHR. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Riva Star?
Riva Star is a medical device that received FDA 510(k) clearance on 2018-04-11. It is manufactured by Sdi Limited. The 510(k) number is K172047.
When was Riva Star approved by the FDA?
Riva Star received FDA 510(k) clearance on 2018-04-11, under approval number K172047.
What company makes Riva Star?
Riva Star is manufactured by Sdi Limited.
What is the FDA product code for Riva Star?
The FDA product code for Riva Star is PHR.
Other Devices by Sdi Limited
Related Devices (Code: PHR)
K222459Centrix FluoroSilver Silver Diamine Fluoride 38%Centrix, Inc.
K222323Black DiamondElevate Oral Care, LLC
K240059FAgamin®Tedequim Srl
K240619e-SDFKids-E-Dental Llp
K250222SDF ProBelport Company, Inc., Gingi-Pak
K241041Silver Fluoride Hypersensitivity VarnishYoung Dental Manufacturing Co. 1, LLC
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.