Kuraray Noritake Dental, Inc. FDA Approvals

0 new drug approvals and 6 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
CERABIEN MiLai510(k)May 29, 2025Dental	Dental	510(k)Substantially Equivalent (Traditional)	May 29, 2025
KATANA Zirconia ONE For IMPLANT510(k)May 24, 2024Dental	Dental	510(k)Substantially Equivalent (Traditional)	May 24, 2024
CLEARFIL Universal Bond Quick 2510(k)Dec 13, 2023Dental	Dental	510(k)Substantially Equivalent (Traditional)	Dec 13, 2023
Esthetic Colorant510(k)Sep 23, 2022Dental	Dental	510(k)Substantially Equivalent (Traditional)	Sep 23, 2022
CERABIEN MiLai510(k)Mar 28, 2022Dental	Dental	510(k)Substantially Equivalent (Traditional)	Mar 28, 2022
PANAVIA Veneer LC510(k)Jun 11, 2021Dental	Dental	510(k)Substantially Equivalent (Traditional)	Jun 11, 2021