510(k) Report

Devices descending from K094007

22 later devices reach Unicem through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100908Unicem HM3M Espe AG Dental Products20101—
+1K100756MALTA3M Espe AG Dental Products201019—
+2K252785TopCEM Vigor SA Self-Adhesive Resin CementRizhao Huge Biomaterials Company, Ltd.20250—
+2K192992Suglue 33M Deutschland GmbH20190—
+2K152691EDS Universal CementEssential Dental Systems, Inc.20160—
+2K120378Panavia SA Cement Handmix Value Pack (Universal (A2), White) Panavia SA Cement Handmix…Kuraray Medical, Inc.20121—
+2K120379Panavia SA Cement Automix Value Pack (Universal (A2), White) Panavia SA Cement Automix…Kuraray Medical, Inc.20125—
+2K110508Suglue-103M Espe AG20118—
+3K183465Allcem, Allcem CoreDentscare Ltda20190—
+3K191548Nexus Universal Self-CureKerr Corporation201901
+3K153231G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi PrimerGC America, Inc.20165—
+3K142623PANAVIA SA Cement Plus HandmixKuraray Noritake Dental, Inc.20150—
+3K142625PANAVIA SA Cement Plus Automix; (Universal (A2), White, Translucent); Value Pack…Kuraray Noritake Dental, Inc.20154—
+4K251946G aenial Universal Injectable IIGC America, Inc.20250—
+4K200798G-Cem OneGC America, Inc.20203—
+4K183537PANAVIA SA Cement UniversalKuraray Noritake Dental, Inc.20190—
+4K150704PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit…Kuraray Noritake Dental, Inc.20152—
+5K254109G-Cem UniversalGC America, Inc.20260—
+5K254063iCEM Universal PlusKulzer, LLC20250—
+5K242366OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment…Overfibers S.R.L.20250—
+5K210504PANAVIA Veneer LCKuraray Noritake Dental, Inc.20210—
+5K191524Visalys Tooth PrimerKettenbach GmbH & Co. KG20190—