Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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

K-Number: K242360 · 2024-11-15

ApplicantDent4you AG
Decision Date2024-11-15
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator is a medical device manufactured by Dent4you AG. It received FDA 510(k) clearance on 2024-11-15 under approval number K242360. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator?

Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator is a medical device that received FDA 510(k) clearance on 2024-11-15. It is manufactured by Dent4you AG. The 510(k) number is K242360.

When was Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator approved by the FDA?

Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator received FDA 510(k) clearance on 2024-11-15, under approval number K242360.

What company makes Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator?

Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator is manufactured by Dent4you AG.

What is the FDA product code for Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator?

The FDA product code for Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator is ELW.

Related Clinical Trials

NCT06913309 Clinical Efficacy, Safety, and Applicability of Home-based Bright Light Therapy in Outpatient Adolescents With Major Depressive Disorder RECRUITING

Other Devices by Dent4you AG

K223142Coltolux Comfort LED Curing Light K240801BioSonic US200 Ultrasonic Scaler (60034537) K250969JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST

Related Devices (Code: ELW)

K152615Vonflex SVericom Co., Ltd. K161774i-SilSpident Co., Ltd. K160097Image Fast Set, Image Regular SetSybron Dental Specialties K160441Identic and KromaFaze Alginate Dental Impression MaterialsKerr Corporation K152826NoCordCentrix, Inc. K152766CharmFlexDentkist, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑