Cleared Traditional

MultiMatch Flow Chameleon AntiMicrobial Composite

Nov 2025
Decision
1d
Days
Class 2
Risk

About This 510(k) Submission

K253513 is an FDA 510(k) clearance for the MultiMatch Flow Chameleon AntiMicrobial Composite, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Premier Dental Products Company (Plymouth Meeting, US). The FDA issued a Cleared decision on November 7, 2025, 1 days after receiving the submission on November 6, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K253513 FDA.gov
FDA Decision Cleared SESE
Date Received November 06, 2025
Decision Date November 07, 2025
Days to Decision 1 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBF — Material, Tooth Shade, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3690

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