Black Diamond

FDA 510(k) K222323 · Elevate Oral Care, LLC

Substantially Equivalent

510(k) numberK222323

Submission

Device name
Black Diamond
Applicant
Elevate Oral Care, LLC
West Palm Beach, FL, US
Received
August 2, 2022
Decision date
June 23, 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

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K250222SDF ProPHR · Traditional Belport Company, Inc., Gingi-Pak05/07/2025SE
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
K172047Riva StarPHR · Traditional Sdi Limited04/11/2018SE
K102973Silver Dental ArrestPHR · Traditional Cooley Consulting, Inc.07/31/2014SE

More from Cooley Consulting, Inc.

510(k)DeviceDecision
K253778Allday Moisturizing RinseLFD · Traditional 02/27/2026SE
K233768Papacarie DuoLBH · Traditional 07/18/2024SE
K150074Elevate Moisturizing SprayLFD · Traditional 06/19/2015SE
K131376Smartcoat 2.5% Naf VarnishLBH · Traditional 08/27/2013SE

Questions and answers

When was Black Diamond cleared by the FDA?

Black Diamond (K222323) received a 510(k) decision of Substantially Equivalent on June 23, 2023, 325 days after the submission was received.

What is the product code of K222323?

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