Handpiece Headquarters FDA Approvals

0 new drug approvals and 2 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
HPR Cordless Hygiene Handpiece510(k)Dec 20, 2024Dental	Dental	510(k)Substantially Equivalent (Traditional)	Dec 20, 2024
BASE290 LED Curing Light510(k)Nov 2, 2023Dental	Dental	510(k)Substantially Equivalent (Traditional)	Nov 2, 2023