Shofu Dental Corporation 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
GlasIonomer FX-LC510(k)Dec 9, 2025Dental	Dental	510(k)Substantially Equivalent (Traditional)	Dec 9, 2025
ZIRCONOMER P510(k)Oct 28, 2025Dental	Dental	510(k)Substantially Equivalent (Traditional)	Oct 28, 2025
ResiCem EX510(k)Jul 11, 2025Dental	Dental	510(k)Substantially Equivalent (Traditional)	Jul 11, 2025
BEAUTIFIL II510(k)May 27, 2025Dental	Dental	510(k)Substantially Equivalent (Traditional)	May 27, 2025
BeautiLink SA510(k)Sep 28, 2023Dental	Dental	510(k)Substantially Equivalent (Traditional)	Sep 28, 2023
GlasIonomer FX ULTRA510(k)Sep 22, 2022Dental	Dental	510(k)Substantially Equivalent (Traditional)	Sep 22, 2022
BeautiBond Xtreme510(k)Mar 18, 2022Dental	Dental	510(k)Substantially Equivalent (Traditional)	Mar 18, 2022
Vintage Prime Press510(k)Mar 18, 2022Dental	Dental	510(k)Substantially Equivalent (Traditional)	Mar 18, 2022
Shofu Block HC Hard510(k)Feb 5, 2021Dental	Dental	510(k)Substantially Equivalent (Traditional)	Feb 5, 2021