Dent4you AG FDA Approvals

0 new drug approvals and 4 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST510(k)Jun 27, 2025Dental	Dental	510(k)Substantially Equivalent (Abbreviated)	Jun 27, 2025
Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator510(k)Nov 15, 2024Dental	Dental	510(k)Substantially Equivalent (Traditional)	Nov 15, 2024
BioSonic US200 Ultrasonic Scaler (60034537)510(k)Jul 1, 2024Dental	Dental	510(k)Substantially Equivalent (Traditional)	Jul 1, 2024
Coltolux Comfort LED Curing Light510(k)Dec 22, 2022Dental	Dental	510(k)Substantially Equivalent (Traditional)	Dec 22, 2022