510(k) Report

Devices descending from K181075

5 later devices reach PureSet Tray through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231219NobelZygoma PureSet™ TrayNobel Biocare Services AG20230—
+1K212932Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC…Nobel Biocare Services AG20212—
+1K191475Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray…Nobel Biocare AB20194—
+2K260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AG20260—
+2K231144WashtraysDentsply Sirona20240—