510(k) Report

Devices descending from K151045

4 later devices reach TENEO Dental Treatment Unit and Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251811Motor and Apex Module (MaAM)Dentsply Sirona, Inc.20250—
+1K233865X-Smart Pro; X-Smart Pro+Dentsply Sirona, Inc.20241—
+1K161488ESTETICA Dental Treatment Unit and AccessoriesKaltenbach & Voigt GmbH20161—
+2K171872P50 Series Dental Operative Unit and AccessoriesPelton & Crane20180—