510(k) Report

Devices descending from K953027

5 later devices reach Permadyne Penta (High & Low Viscosity) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K994193Impregum Penta DuosoftEspe Dental AG20003—
+1K991221VestogumEspe Dental AG19990—
+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—