510(k) Report

Devices descending from K960547

11 later devices reach Dimension Penta/Dimension Garant L/Polyvinyl Siloxane Adhesive through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K991008Dimension BiteEspe Dental AG19991—
+1K984248ProcemEspe Dental AG19990—
+1K974231Position Penta, Position Penta QuickEspe GmbH & Co. Kg.19988—
+2K133400Flash Bite3M Espe AG20140—
+2K131404Flash AR Penta / Flash AR Penta Quick3M Deutschland GmbH20132—
+2K091826Elegant3M Espe AG Dental Products20090—
+2K090718Bellus Shading Kit3M Espe AG Dental Products20091—
+2K082157Kettosil and SilginatKettenbach GmbH & Co. KG20080—
+2K013237StatusblueDmg USA, Inc.20010—
+3K133436Flash AR; Flash AR Quick3M Deutschland GmbH20140—
+3K130604Universal Paste Stains and GlazePrismatik Dentalcraft, Inc.20130—