Ultradent Products, Inc. FDA Approvals

0 new drug approvals and 9 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
Transcend Bulk Fill Flowable Composite510(k)Jul 1, 2026Dental	Dental	510(k)Substantially Equivalent (Traditional)	Jul 1, 2026
UltraEZ510(k)Apr 30, 2026Dental	Dental	510(k)Substantially Equivalent (Special)	Apr 30, 2026
Peak Universal Bond510(k)Mar 20, 2024Dental	Dental	510(k)Substantially Equivalent (Special)	Mar 20, 2024
FORMA Composite (Shade A3D)510(k)Mar 15, 2024Dental	Dental	510(k)Substantially Equivalent (Traditional)	Mar 15, 2024
J-Temp510(k)Jul 1, 2022Dental	Dental	510(k)Substantially Equivalent (Traditional)	Jul 1, 2022
VALO X, VALO X Accessory Lenses510(k)Feb 22, 2022Dental	Dental	510(k)Substantially Equivalent (Traditional)	Feb 22, 2022
UltraCal XS510(k)Oct 13, 2021Dental	Dental	510(k)Substantially Equivalent (Traditional)	Oct 13, 2021
UltraTemp Rez II510(k)Jul 13, 2021Dental	Dental	510(k)Substantially Equivalent (Traditional)	Jul 13, 2021
VALO Grand Corded and Accessory Lenses510(k)Mar 1, 2021Dental	Dental	510(k)Substantially Equivalent (Traditional)	Mar 1, 2021