510(k) Report

Devices descending from K953374

6 later devices reach Permadyne Garant 2:1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K994190Impregum Garant L DuosoftEspe Dental AG20003—
+1K991008Dimension BiteEspe Dental AG19991—
+2K133400Flash Bite3M Espe AG20140—
+2K032001Poly Q (Garant L, Penta M, Penta H)3M Espe AG Dental Products20032—
+3K173318Rapid HB, Rapid LB, Rapid MB3M Deutschland GmbH20170—
+3K080514Pecd-01 and Pecd Quick-013M Espe AG Dental Products20080—