510(k) Report

Devices descending from K811767

2 later devices reach Coltene President Impression Materials through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220097PRESIDENT The OriginalColtène/Whaledent AG20221—
+2K242360Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal…Dent4you AG20240—