Changzhou Bomedent Medical Technology Co.,Ltd 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
Ultrasonic Endo Activation Device (Model:Actor I pro)510(k)Sep 8, 2022Dental	Dental	510(k)Substantially Equivalent (Traditional)	Sep 8, 2022
BOMEDENT Apex locator, WISMY Apex locator510(k)Mar 30, 2021	—	510(k)Substantially Equivalent (Traditional)	Mar 30, 2021