EKJ — Burnisher, Operative Class I

FDA Device Classification

Classification Details

Product Code
EKJ
Device Class
Class I
Regulation Number
872.4565
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K961714distriflorASEPTYLUM, UNI-CARRIERJune 10, 1996
K953707medtrolMEDTROL DENTAL KITJanuary 4, 1996
K945815constancy entDENTAL KITJuly 19, 1995
K951607dentsply intlSUREFLEX FILESJune 22, 1995
K945077worldwide dentalINSTRUMENT,FILLING,PLASTIC,DENTALNovember 30, 1994
K943820magnum instrumentsSTAT PAKNovember 2, 1994
K943351magnum instrumentsMAUNAL DISPOSABLE DENTAL INSTRUMENTSOctober 7, 1994
K943584dentsply intlPRESTERILIZED ENDODONTIC FILESSeptember 21, 1994
K935127southlandSOUTHLAND STERILE DENTAL SYSTEMJuly 28, 1994
K941954buffalo dental mfg. coNON-FOGGING DENTAL MIRRORJuly 8, 1994
K925115advance medical designsAMD DENTIST AND HYGIENIST KITSJuly 5, 1994
K925890protectorMIRROR, MOUTHFebruary 15, 1994
K925888protectorEXPLORER, OPERATIVEFebruary 15, 1994
K925889protectorFORCEPS, DRESSING, DENTALFebruary 15, 1994
K935217l.c. dentalLC DENTAL HAND INSTRUMENTJanuary 5, 1994
K932511moyco industriesSILICONE MIRRORNovember 5, 1993
K926368centrixAPPLICATOR NOZZLESeptember 15, 1993
K923902professional sterile systemsSTERILE DENTAL KITSJune 29, 1993
K922988dyna-pace systemsECO/DENTAL GENERAL DENTAL PACKNovember 4, 1992
K921354innovatorsBLUNT TIP IRRIGATION NEEDLESSeptember 25, 1992