Cleared Traditional

Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator

K242360 · Dent4you AG · Dental
Nov 2024
Decision
98d
Days
Class 2
Risk

About This 510(k) Submission

K242360 is an FDA 510(k) clearance for the Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator, a Material, Impression (Class II — Special Controls, product code ELW), submitted by Dent4you AG (Heerbrugg, CH). The FDA issued a Cleared decision on November 15, 2024, 98 days after receiving the submission on August 9, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3660.

Submission Details

510(k) Number K242360 FDA.gov
FDA Decision Cleared SESE
Date Received August 09, 2024
Decision Date November 15, 2024
Days to Decision 98 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code ELW — Material, Impression
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3660

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