510(k) Report

Devices descending from K994192

3 later devices reach Impregum Penta M Monosoft through their predicates, nearest generation first.

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