510(k) Report

Devices descending from K191382

3 later devices reach IPS e.max CAD Abutment Solutions- extra systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221402CEREC Tessera Abutment Block, CEREC Tessera Abutment SystemDentsply Sirona, Inc.20232—
+2K252248CEREC Tessera Abutment SystemDentsply Sirona20250—
+2K234018CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment SystemDentsply Sirona20240—