Prevest Denpro Limited FDA Approvals

0 new drug approvals and 7 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
C&B Ceramic; C&B Permanent; C&B Interim510(k)Nov 27, 2024Dental	Dental	510(k)Substantially Equivalent (Traditional)	Nov 27, 2024
Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT510(k)Jan 5, 2024Dental	Dental	510(k)Substantially Equivalent (Traditional)	Jan 5, 2024
Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal510(k)Aug 11, 2023Dental	Dental	510(k)Substantially Equivalent (Traditional)	Aug 11, 2023
Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration)510(k)Sep 9, 2022Dental	Dental	510(k)Substantially Equivalent (Traditional)	Sep 9, 2022
CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid510(k)May 23, 2022Dental	Dental	510(k)Substantially Equivalent (Traditional)	May 23, 2022
Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)510(k)May 13, 2022Dental	Dental	510(k)Substantially Equivalent (Traditional)	May 13, 2022
Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner)510(k)May 13, 2021Dental	Dental	510(k)Substantially Equivalent (Traditional)	May 13, 2021