Home / Device Classification / EKS

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
K905640hygenicSOLID CORE GUTTA PERCHA CARRIERMarch 5, 1991
K905461angiosystemsPROCEDURE KIT/ROUTINE DENTAL PROCEDURESMarch 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
K864922e and d dental manufacturingDENTAL HANDPIECES AND ATTACHMENTFebruary 19, 1987