Centrix FluoroSilver Silver Diamine Fluoride 38%

Q: What is the product code of K222459?

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) K222459 · Centrix, Inc.

Substantially Equivalent

510(k) numberK222459

Submission

Device name: Centrix FluoroSilver Silver Diamine Fluoride 38%
Applicant: Centrix, Inc.
Shelton, CT, US
Received: August 15, 2022
Decision date: October 27, 2023
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
K222323	Black DiamondPHR · Traditional	Elevate Oral Care, LLC	06/23/2023SE
K172047	Riva StarPHR · Traditional	Sdi Limited	04/11/2018SE
K102973	Silver Dental ArrestPHR · Traditional	Cooley Consulting, Inc.	07/31/2014SE

More from Cooley Consulting, Inc.

510(k)	Device	Decision
K250714	FluoroDose VarnishLBH · Traditional	11/21/2025SE
K200764	StatstixMVL · Traditional	10/15/2020SE
K152826	NoCordELW · Traditional	05/27/2016SE
K140144	Benda WedgeEJB · Traditional	07/08/2014SE
K120176	Senzzzzz AwayLBH · Traditional	07/25/2012SE
K111348	Re / Stasis (TM) Gingival Retraction PasteMVL · Traditional	07/22/2011SE
K092384	LiquicordMVL · Traditional	11/04/2009SE
K091380	CordcapMVL · Traditional	07/30/2009SE
K021131	ChloraprepLBH · Traditional	09/26/2002SE
K021146	D/Sense 1-STEPEJK · Traditional	07/02/2002SE

Questions and answers

When was Centrix FluoroSilver Silver Diamine Fluoride 38% cleared by the FDA?

Centrix FluoroSilver Silver Diamine Fluoride 38% (K222459) received a 510(k) decision of Substantially Equivalent on October 27, 2023, 438 days after the submission was received.

What is the product code of K222459?

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