510(k) K242360

Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator by Dent4you AG — Product Code ELW

K242360 is an FDA 510(k) premarket notification submitted by Dent4you AG for the device "Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator". The FDA issued a decision of Substantially Equivalent on November 15, 2024. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. Dent4you AG has at least 3 other 510(k) clearances on record.