FDA 510(k) Applications for Medical Device Product Code "DZI"
(Drill, Bone, Powered)

FDA 510(k) Number Applicant Device Name Decision Date
K871648 ASPEN LABORATORIES, INC. TMJ CANNULA SET 06/08/1987
K080761 BONART CO. LTD. BONART'S ARTEOTOMY OMI AND OPI ULTRASONIC SURGERY SYSTEM & ACCESSORIES 08/25/2008
K152125 BONART CO., LTD. Oral Surgery System and Accessories 08/15/2016
K121620 DMETEC CO., LTD. ULTRASONIC SURGERY 12/11/2012
K113152 DMETEC CO., LTD. ULTRASONIC SURGERY MACHINE 06/14/2012
K150076 DONG IL TECHNOLOGY LTD. Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L 06/02/2015
K110881 DONG IL TECHNOLOGY LTD. ULTRASONIC SURGICAL UNIT 12/16/2011
K072146 E.M.S. ELECTRO MEDICAL SYSTEMS S.A. EMS PIEZON MASTER SURGERY 12/18/2007
K111290 GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD PIEZO BONE SURGERY 11/18/2011
K080220 ITALIA MEDICA S.R.L. PIEZO ULTRASONIC DEVICE, MODEL ULTRASONIC BONE SURGERY; ULTRASONIC DEBRIDMENT DEVICE 07/28/2008
K803291 JEDMED INSTRUMENT CO. ARTUS DRILL #2000 01/28/1981
K803290 JEDMED INSTRUMENT CO. ARTUS DRILL #3000 01/28/1981
K803289 JEDMED INSTRUMENT CO. ARTUS DRILL #4000 01/28/1981
K803288 JEDMED INSTRUMENT CO. ARTUS DRILL #6000 01/28/1981
K060270 LINVATEC CORP. MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL 04/10/2006
K032607 LINVATEC CORP. POWERPRO PNEUMATIC SYSTEM, MODELS PRO6150, PRO6175, PRO6185 11/10/2003
K171326 Mectron S.p.a Piezosurgery White 04/13/2018
K122322 MECTRON S.P.A. PIEZOSURGERY TOUCH 12/06/2012
K171958 Mectron SPA PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE 01/12/2018
K151248 MECTRON SPA PIEZOSURGERY WHITE 09/04/2015
K874535 MICROTEK MEDICAL, INC. MICROTEK "MINI-MAX" DRILL SYSTEM 11/23/1987
K073678 NAKANISHI, INC. VARIOSURG 07/10/2008
K990846 NOBEL BIOCARE UAS INC AMORPHOUS DIAMOND COATED DRILL 06/10/1999
K042434 NOUVAG AG MICRO-MOTORSYSTEMS MD20, SEM2, HIGHSURG 20 & DT55 11/03/2004
K091227 PIEZOSURGERY S.R.L. PIEZOSURGERY 3; OSSTEM PIEZO 12/29/2009
K043408 PIEZOSURGERY SRL PIEZOSURGERY DEVICE 06/08/2005
K151171 SAESHIN PRECISION CO., LTD. TRAUS SUS10 09/01/2015
K091252 SATELEC IMPLANT CENTER 2 07/22/2009
K060274 SATELEC PIEZOTOME 05/01/2006
K091331 SATELEC PIEZOTOME 2 12/11/2009
K172137 Satelec - Acteon Group PIEZOTOME CUBE 05/03/2018
K112188 SATELEC - ACTEON, INC. PIEZOTOME SOLO 02/03/2012
K072030 SATELEC-ACTEON GROUP IMPLANT CENTER 11/19/2007
K791326 SHERWOOD MEDICAL CO. MONOJECT ENDOSSEOUS DENTAL IMPLANT TOOL 10/17/1979
K083569 SILFRADENT S.R.L. SURGYBONE 04/01/2009
K082532 STRAUMANN USA STRAUMANN GUIDED INSTRUMENTS 10/21/2008
K954690 STRYKER CORP. STRYKER ORAL MAX SYSTEM 08/20/1996
K991696 STRYKER INSTRUMENTS STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEM 10/25/1999
K032117 STRYKER INSTRUMENTS STRYKER TOTAL PERFORMANCE (TPS) SYSTEM 08/08/2003
K082649 SYNTHES (USA) SYNTHES 90 DEGREE SCREWDRIVER 04/30/2009
K133488 W & H DENTALWERK BUERMOOS GMBH PIEZOMED 10/16/2014


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