Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator— 510(k) K242360

Name: FDA 510(k) clearance K242360
Creator: U.S. Food and Drug Administration
Published: 2024-11-15

Substantially Equivalent

Dent4you AG

FDA 510(k) clearance K242360 for Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator, Substantially Equivalent on 2024-11-15. Applicant: Dent4you AG. Device class: 2.

Clearance details

Applicant: Dent4you AG
Product code: Code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 2024-08-09
Decision date: 2024-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Heerbrugg, CH

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.