Device Atlas

Silver Dental Arrest

Q: What is the product code of K102973?

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) K102973 · Cooley Consulting, Inc.

Substantially Equivalent

510(k) numberK102973

Submission

Device name: Silver Dental Arrest
Applicant: Cooley Consulting, Inc.
Wyoming, OH, US
Received: October 6, 2010
Decision date: July 31, 2014
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement 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
K172047	Riva StarPHR · Traditional	Sdi Limited	04/11/2018SE

Questions and answers

When was Silver Dental Arrest cleared by the FDA?

Silver Dental Arrest (K102973) received a 510(k) decision of Substantially Equivalent on July 31, 2014, 1,394 days after the submission was received.

What is the product code of K102973?

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