Paragon Implant Mfg., LLC FDA Approvals

0 new drug approvals and 5 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
TriActive Dental Implant System510(k)Sep 17, 2026Dental	Dental	510(k)Substantially Equivalent (Abbreviated)	Sep 17, 2026
GEN5 and GEN5+ 3.3mmD Dental Implants510(k)Dec 23, 2025Dental	Dental	510(k)Substantially Equivalent (Traditional)	Dec 23, 2025
NizPlant Dental Implant System510(k)Dec 23, 2025Dental	Dental	510(k)Substantially Equivalent (Abbreviated)	Dec 23, 2025
Sterilization Trays510(k)Nov 14, 2025General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Nov 14, 2025
GEN5 and GEN5+ Dental Implant System510(k)Oct 30, 2025Dental	Dental	510(k)Substantially Equivalent (Traditional)	Oct 30, 2025