Cleared Traditional

Partial Flex

K242897 · Clemde SA DE CV · Dental
Jun 2025
Decision
253d
Days
Class 2
Risk

About This 510(k) Submission

K242897 is an FDA 510(k) clearance for the Partial Flex, a Resin, Denture, Relining, Repairing, Rebasing (Class II — Special Controls, product code EBI), submitted by Clemde SA DE CV (Mexico City, MX). The FDA issued a Cleared decision on June 3, 2025, 253 days after receiving the submission on September 23, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3760.

Submission Details

510(k) Number K242897 FDA.gov
FDA Decision Cleared SESE
Date Received September 23, 2024
Decision Date June 03, 2025
Days to Decision 253 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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