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EKS — File, Pulp Canal, Endodontic Class I

FDA Device Classification

Classification Details

Product Code
EKS
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
K062856ormcoTF ROTARY NICKEL TITANIUM FILEDecember 13, 2006
K004031dental powerNT SWIFT; TI\TEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC HAND FILESMarch 28, 2001
K971319tycom dentalNT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILESMay 22, 1997
K970649micro-megaHERO 642May 16, 1997
K962031tycom dentalQUANTEC SERIES 2000 ENDODONTIC FILESJune 4, 1996
K953604sybron dental specialtiesSHAPING HEDSTROM N.T.September 28, 1995
K935542union broach, div. moyco industriesNICKEL-TITANIUM K-TYPE FILEJanuary 3, 1994
K932529lightspeed endodonticsLIGHTSPEED DENTAL HAND INSTRUMENTNovember 4, 1993
K933582tulsa dental productsPROFILE SERIES 29 FILESOctober 20, 1993
K902018dentauraumDENTAURUM CERAMIC DEBONDING UNITApril 3, 1991
K905461angiosystemsPROCEDURE KIT/ROUTINE DENTAL PROCEDURESMarch 5, 1991
K905640hygenicSOLID CORE GUTTA PERCHA CARRIERMarch 5, 1991
K901037j. morita usaVISIONER 21-AAugust 14, 1990
K897195a companyA-COMPANY ELECTROTHERMAL DEBONDING DEVICE (ETD)May 31, 1990
K883418scheu-dentalDE-BOND 200October 24, 1989
K892861u.s. dentekDENTAL PIKSeptember 15, 1989
K892894svenska dental instrumentsS-FILE, S-FINDER, S-ENGINE FILEMay 24, 1989
K873671colteneCOLTENE PRESIDENT JET IMPRESSION MATERIALS SYSTEMOctober 27, 1987
K864976endo technicSOLUSET CALCIUM DEMINERALIZING SOLUTIONFebruary 27, 1987
K870177c and s microinstrumentsENDOBRUSHFebruary 19, 1987