Pac-Dent, Inc. FDA Approvals

0 new drug approvals and 7 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
Medidenta High Speed Handpieces510(k)Dec 12, 2022Dental	Dental	510(k)Substantially Equivalent (Traditional)	Dec 12, 2022
OptiComp510(k)May 25, 2022Dental	Dental	510(k)Substantially Equivalent (Traditional)	May 25, 2022
The iMask Child's Face Mask510(k)Aug 26, 2021General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Aug 26, 2021
Pac-Dent Denture Base Resin510(k)Jul 28, 2021Dental	Dental	510(k)Substantially Equivalent (Traditional)	Jul 28, 2021
Pac-Dent Ceramic Nanohybrid Resin510(k)Jul 26, 2021Dental	Dental	510(k)Substantially Equivalent (Traditional)	Jul 26, 2021
PacBond One510(k)Jul 16, 2021Dental	Dental	510(k)Substantially Equivalent (Traditional)	Jul 16, 2021
iMask Disposable Surgical Face Mask510(k)Feb 19, 2021General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Feb 19, 2021