Sdi Limited FDA Approvals

0 new drug approvals and 3 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
Stela Capsule System510(k)Oct 28, 2022Dental	Dental	510(k)Substantially Equivalent (Traditional)	Oct 28, 2022
Stela Automix System510(k)Oct 28, 2022Dental	Dental	510(k)Substantially Equivalent (Traditional)	Oct 28, 2022
Riva Cem Automix510(k)Aug 30, 2022Dental	Dental	510(k)Substantially Equivalent (Traditional)	Aug 30, 2022