Cleared Traditional

FAgamin?

K240059 · Tedequim Srl · Dental
May 2024
Decision
129d
Days
Class 2
Risk

About This 510(k) Submission

K240059 is an FDA 510(k) clearance for the FAgamin?, a Diammine Silver Fluoride Dental Hypersensitivity Varnish (Class II — Special Controls, product code PHR), submitted by Tedequim Srl (C?rdoba, AR). The FDA issued a Cleared decision on May 16, 2024, 129 days after receiving the submission on January 8, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3260.

Submission Details

510(k) Number K240059 FDA.gov
FDA Decision Cleared 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

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.