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DZI — Drill, Bone, Powered Class II

FDA Device Classification

Classification Details

Product Code
DZI
Device Class
Class II
Regulation Number
872.4120
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K254163nakanishiVarioSurg 4December 23, 2025
K242432mectronMT-BoneAugust 19, 2024
K240340guangdong jinme medical technology coSurgical Drive System (Model: ES70, ES90, E8)July 18, 2024
K231087implant direct sybron manufacturingGuided Surgery KitAugust 16, 2023
K192561saeshin precision coTRAUS SUS20July 13, 2020
K200265implant direct sybron manufacturingSurgical DrillsJune 30, 2020
K192033bennett jacoby, dds, msContour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-InJune 9, 2020
K172137satelec - acteon groupPIEZOTOME CUBEMay 3, 2018
K171326mectronPiezosurgery WhiteApril 13, 2018
K171958mectronPIEZOSURGERY TOUCH, PIEZOSURGERY WHITEJanuary 12, 2018
K152125bonart coOral Surgery System and AccessoriesAugust 15, 2016
K151248mectronPIEZOSURGERY WHITESeptember 4, 2015
K151171saeshin precision coTRAUS SUS10September 1, 2015
K150076dong il technologySonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800LJune 2, 2015
K133488w and h dentalwerk buermoosPIEZOMEDOctober 16, 2014
K121620dmetec.coULTRASONIC SURGERYDecember 11, 2012
K122322mectronPIEZOSURGERY TOUCHDecember 6, 2012
K113152dmetec.coULTRASONIC SURGERY MACHINEJune 14, 2012
K112188satelec - acteonPIEZOTOME SOLOFebruary 3, 2012
K110881dong il technologyULTRASONIC SURGICAL UNITDecember 16, 2011