510(k) Report

Devices descending from K062828

6 later devices reach Mouthguard and Aligner Materials through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200125Thermoforming Sheet MaterialsErkodent Erich Kopp GmbH20201—
+1K134015M-PM-DiscMerz Dental GmbH20141—
+1K072522Thermoform Sheet Materials and AccessoriesDentsply International, Inc.20073—
+2K241311Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B)…Bernhard Förster GmbH20240—
+2K191836Ceramill A-SplintAmann Girrbach AG20190—
+2K080246Composite Aligner ButtonDentsply Interntional20080—