Cleared Traditional

Black Diamond

K222323 · Elevate Oral Care, LLC · Dental
Jun 2023
Decision
325d
Days
Class 2
Risk

About This 510(k) Submission

K222323 is an FDA 510(k) clearance for the Black Diamond, a Diammine Silver Fluoride Dental Hypersensitivity Varnish (Class II — Special Controls, product code PHR), submitted by Elevate Oral Care, LLC (West Palm Beach, US). The FDA issued a Cleared decision on June 23, 2023, 325 days after receiving the submission on August 2, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.3260.

Submission Details

510(k) Number K222323 FDA.gov
FDA Decision Cleared SESE
Date Received August 02, 2022
Decision Date June 23, 2023
Days to Decision 325 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code PHR — Diammine Silver Fluoride Dental Hypersensitivity Varnish
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3260
Definition Applied To Tooth Enamel To Block Dentinal Tubules For The Purpose Of Reducing Tooth Sensitivity.