Cleared Traditional

K222323 - Black Diamond (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K222323 · Elevate Oral Care, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2023
Decision
325d
Days
Class 2
Risk

K222323 is an FDA 510(k) clearance for the Black Diamond. Classified as Diammine Silver Fluoride Dental Hypersensitivity Varnish (product code PHR), Class II - Special Controls.

Submitted by Elevate Oral Care, LLC (West Palm Beach, US). The FDA issued a Cleared decision on June 23, 2023 after a review of 325 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3260 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Elevate Oral Care, LLC devices

Submission Details

510(k) Number K222323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
198d slower than avg
Panel avg: 127d · This submission: 325d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PHR Diammine Silver Fluoride Dental Hypersensitivity Varnish
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3260
Definition Applied To Tooth Enamel To Block Dentinal Tubules For The Purpose Of Reducing Tooth Sensitivity.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Consultant

Elevate Oral Care
Steve Pardue

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - PHR Diammine Silver Fluoride Dental Hypersensitivity Varnish

All 7
Devices cleared under the same product code (PHR) and FDA review panel - the closest regulatory comparables to K222323.
SDF Pro
K250222 · Belport Company, Inc., Gingi-Pak · May 2025
Silver Fluoride Hypersensitivity Varnish
K241041 · Young Dental Manufacturing Co. 1, LLC · Feb 2025
FAgamin®
K240059 · Tedequim Srl · May 2024
e-SDF
K240619 · Kids-E-Dental Llp · Mar 2024
Centrix FluoroSilver Silver Diamine Fluoride 38%
K222459 · Centrix, Inc. · Oct 2023