Cleared Traditional

K240059 - FAgamin® (FDA 510(k) Clearance)

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

K240059 · Tedequim Srl · Dental device
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Optimized for regulatory review, auditing and printing
May 2024
Decision
129d
Days
Class 2
Risk

K240059 is an FDA 510(k) clearance for the FAgamin®. Classified as Diammine Silver Fluoride Dental Hypersensitivity Varnish (product code PHR), Class II - Special Controls.

Submitted by Tedequim Srl (Córdoba, AR). The FDA issued a Cleared decision on May 16, 2024 after a review of 129 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Tedequim Srl devices

Submission Details

510(k) Number K240059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2024
Decision Date May 16, 2024
Days to Decision 129 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
2d slower than avg
Panel avg: 127d · This submission: 129d
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

Compliance4Devices
Juan Tezak

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 K240059.
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K241041 · Young Dental Manufacturing Co. 1, LLC · Feb 2025
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K240619 · Kids-E-Dental Llp · Mar 2024
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K222323 · Elevate Oral Care, LLC · Jun 2023