Cleared Traditional

K222459 - Centrix FluoroSilver Silver Diamine Fluoride 38% (FDA 510(k) Clearance)

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

K222459 · Centrix, Inc. · Dental device
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Oct 2023
Decision
438d
Days
Class 2
Risk

K222459 is an FDA 510(k) clearance for the Centrix FluoroSilver Silver Diamine Fluoride 38%. Classified as Diammine Silver Fluoride Dental Hypersensitivity Varnish (product code PHR), Class II - Special Controls.

Submitted by Centrix, Inc. (Shelton, US). The FDA issued a Cleared decision on October 27, 2023 after a review of 438 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Centrix, Inc. devices

Submission Details

510(k) Number K222459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2022
Decision Date October 27, 2023
Days to Decision 438 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
311d slower than avg
Panel avg: 127d · This submission: 438d
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

Aztech Regulatory & Quality, LLC
Joseph Azary

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.