SDF Pro

FDA 510(k) K250222 · Belport Company, Inc., Gingi-Pak

Substantially Equivalent

510(k) numberK250222

Submission

Device name
SDF Pro
Applicant
Belport Company, Inc., Gingi-Pak
Camarillo, CA, US
Received
January 27, 2025
Decision date
May 7, 2025
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

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K241041Silver Fluoride Hypersensitivity VarnishPHR · Traditional Young Dental Manufacturing Co. 1, LLC02/28/2025SE
K240059FAgamin®PHR · Traditional Tedequim Srl05/16/2024SE
K240619e-SDFPHR · Traditional Kids-E-Dental Llp03/06/2024SE
K222459Centrix FluoroSilver Silver Diamine Fluoride 38%PHR · Traditional Centrix, Inc.10/27/2023SE
K222323Black DiamondPHR · Traditional Elevate Oral Care, LLC06/23/2023SE
K172047Riva StarPHR · Traditional Sdi Limited04/11/2018SE
K102973Silver Dental ArrestPHR · Traditional Cooley Consulting, Inc.07/31/2014SE

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Questions and answers

When was SDF Pro cleared by the FDA?

SDF Pro (K250222) received a 510(k) decision of Substantially Equivalent on May 7, 2025, 100 days after the submission was received.

What is the product code of K250222?

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