Cleared Traditional

Freeprint? denture flex

K252430 · Detax GmbH · Dental
Oct 2025
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K252430 is an FDA 510(k) clearance for the Freeprint? denture flex, a Resin, Denture, Relining, Repairing, Rebasing (Class II — Special Controls, product code EBI), submitted by Detax GmbH (Ettingen, DE). The FDA issued a Cleared decision on October 30, 2025, 90 days after receiving the submission on August 1, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3760.

Submission Details

510(k) Number K252430 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 2025
Decision Date October 30, 2025
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBI — Resin, Denture, Relining, Repairing, Rebasing
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3760

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