FDA 510(k) Applications for Medical Device Product Code: EKZ (Unit, Electrosurgical, And Accessories, Dental)

FDA 510(k) Applications for Medical Device Product Code "EKZ"
(Unit, Electrosurgical, And Accessories, Dental)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K962445	ARTHROCARE CORP.	ARTHROCARE DENTAL ELECTROSURGERY SYSTEM	07/30/1996
K071632	COLTENE/WHALEDENT INC.	PERFECT TISSUE CONTOURING SYSTEM II	10/18/2007
K020080	DIAGNOSTIC DATA, INC.	BONART ART-E1 ELECTROSURGERY UNIT	02/19/2002
K955176	ELLMAN INTL., INC.	DENTO-SURGE	04/15/1996
K213477	J. Morita USA, Inc.	Root ZX3	08/03/2022
K052622	MACAN ENGINEERING CO.	MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT	12/09/2005
K050735	MACAN ENGINEERING CO.	MC6A	05/23/2005
K063468	MEDISURG LTD.	THE FUGO BLADE FOR DENTISTRY	04/18/2007
K001560	ODONTO-WAVE	ODONTOSURGE 3	08/24/2000
K981390	PERIOGIENE	ODONTOSURGE 2	06/11/1998
K982229	VALLEY FORGE SCIENTIFIC CORP.	BI-DENT	08/13/1998
K000768	WALLACH SURGICAL DEVICES, INC.	WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR	04/11/2000
K023672	XO CARE A/S	X O ODONTOSURGE 4	04/29/2003