Riva Star

Q: When was Riva Star cleared by the FDA?

Riva Star (K172047) received a 510(k) decision of Substantially Equivalent on April 11, 2018, 279 days after the submission was received.

Q: What is the product code of K172047?

The FDA product code is PHR – Diammine Silver Fluoride Dental Hypersensitivity Varnish, a Class II (moderate risk) device regulated under 21 CFR 872.3260.

FDA 510(k) K172047 · Sdi Limited

Substantially Equivalent

510(k) numberK172047

Submission

Device name: Riva Star
Applicant: Sdi Limited
Bayswater, AU
Received: July 6, 2017
Decision date: April 11, 2018
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: PHR – Diammine Silver Fluoride Dental Hypersensitivity Varnish
Device class: Class II (moderate risk)
Regulation: 21 CFR 872.3260
Specialty: Dental

Applied to tooth enamel to block dentinal tubules for the purpose of reducing tooth sensitivity.

Other 510(k)s with product code PHR

510(k)	Device	Applicant	Decision
K250222	SDF ProPHR · Traditional	Belport Company, Inc., Gingi-Pak	05/07/2025SE
K241041	Silver Fluoride Hypersensitivity VarnishPHR · Traditional	Young Dental Manufacturing Co. 1, LLC	02/28/2025SE
K240059	FAgamin®PHR · Traditional	Tedequim Srl	05/16/2024SE
K240619	e-SDFPHR · Traditional	Kids-E-Dental Llp	03/06/2024SE
K222459	Centrix FluoroSilver Silver Diamine Fluoride 38%PHR · Traditional	Centrix, Inc.	10/27/2023SE
K222323	Black DiamondPHR · Traditional	Elevate Oral Care, LLC	06/23/2023SE
K102973	Silver Dental ArrestPHR · Traditional	Cooley Consulting, Inc.	07/31/2014SE

More from Cooley Consulting, Inc.

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K214118	Riva Cem AutomixEMA · Traditional	08/30/2022SE
K191656	ZipbondKLE · Traditional	12/02/2019SE
K102984	AuraEBF · Traditional	12/08/2010SE
K081273	Ultracaps SOIV · Traditional	07/10/2008SE
K073043	Set PPEMA · Traditional	12/14/2007SE
K833176	Sdi Surgical DrapeKKX · Traditional	04/04/1984SE

Questions and answers

When was Riva Star cleared by the FDA?

Riva Star (K172047) received a 510(k) decision of Substantially Equivalent on April 11, 2018, 279 days after the submission was received.

What is the product code of K172047?

The FDA product code is PHR – Diammine Silver Fluoride Dental Hypersensitivity Varnish, a Class II (moderate risk) device regulated under 21 CFR 872.3260.