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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drill, Bone, Powered
510(k) Number K172137
Device Name PIEZOTOME CUBE
Applicant
Satelec - Acteon Group
17 Ave. Gustave Eiffel
Merignac,  FR 33708
Applicant Contact Philippe Girard
Correspondent
Satelec - Acteon Group
124 Gaither Dr. Suite #140
Mt. Laurel,  NJ  08054
Correspondent Contact Argie Zoubroulis
Regulation Number872.4120
Classification Product Code
DZI  
Date Received07/17/2017
Decision Date 05/03/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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