Encore Guards FDA Approvals

0 new drug approvals and 2 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
enCore Impression Material510(k)Mar 17, 2026Dental	Dental	510(k)Substantially Equivalent (Traditional)	Mar 17, 2026
enCore Night Guard510(k)Nov 25, 2025	—	510(k)Substantially Equivalent (Traditional)	Nov 25, 2025