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EKZ — Unit, Electrosurgical, And Accessories, Dental Class II

FDA Device Classification

Classification Details

Product Code
EKZ
Device Class
Class II
Regulation Number
872.4920
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K213477j. morita usaRoot ZX3August 3, 2022
K071632coltene/whaledentPERFECT TISSUE CONTOURING SYSTEM IIOctober 18, 2007
K063468medisurgTHE FUGO BLADE FOR DENTISTRYApril 18, 2007
K052622macan engineeringMACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNITDecember 9, 2005
K050735macan engineeringMC6AMay 23, 2005
K023672xo careX O ODONTOSURGE 4April 29, 2003
K020080diagnostic dataBONART ART-E1 ELECTROSURGERY UNITFebruary 19, 2002
K001560odonto-waveODONTOSURGE 3August 24, 2000
K000768wallach surgical devicesWALLACH QUANTUM 500 ELECTROSURGICAL GENERATORApril 11, 2000
K982229valley forge scientificBI-DENTAugust 13, 1998
K981390periogieneODONTOSURGE 2June 11, 1998
K962445arthrocareARTHROCARE DENTAL ELECTROSURGERY SYSTEMJuly 30, 1996
K955176ellman intlDENTO-SURGEApril 15, 1996
K950239parkellSENSIMATIC 500SEJune 6, 1995
K925116premierELECTROSURGICAL ELECTRODEMarch 1, 1994
K921604analytic technologyTOUCH N' HEAT, MODIFICATIONAugust 24, 1992
K852522spelnaSATALEC SERVOTOMEDecember 27, 1985
K850666ipcoSTROBEX ULTRON ELECTROSURGE-DENTAL UNITMay 29, 1985
K830441coulter electronicsDIFF 4 SYSTEMMay 16, 1983