510(k) Report

Devices descending from K191475

4 later devices reach Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic… through their predicates, nearest generation first.

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