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FDA 510(k) Applications Submitted by Bien-Air Surgery SA
FDA 510(k) Number
Submission Date
Device Name
Applicant
K173066
09/29/2017
OSSEODUO Shaver and Drill System
Bien-Air Surgery SA
K083720
12/15/2008
OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K
BIEN-AIR SURGERY SA
K221184
04/25/2022
ORiGO System
Bien-Air Surgery SA
K213697
11/23/2021
ORiGO System
Bien-Air Surgery SA
K143492
12/08/2014
OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece
Bien-Air Surgery SA
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