510(k) Report

Devices descending from K083720

5 later devices reach Osseoduo, Shaver Handpiece S80 and S120, Micromotor 80K through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221184ORiGO SystemBien-Air Surgery SA20220—
+1K173066OSSEODUO Shaver and Drill SystemBien-Air Surgery SA20183—
+2K233153Traus SSG10 Surgical SystemSaeshin Precision Co., Ltd.20240—
+2K232938Traus SSG30 Surgical SystemSaeshin Precision Co., Ltd.20240—
+2K213697ORiGO SystemBien-Air Surgery SA20220—