FDA 510(k) Applications for Medical Device Product Code "EKS"
(File, Pulp Canal, Endodontic)

FDA 510(k) Number Applicant Device Name Decision Date
K004031 DENTAL POWER, INC. NT SWIFT; TI\TEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC HAND FILES 03/28/2001
K970649 MICRO-MEGA HERO 642 05/16/1997
K062856 ORMCO CORP. TF ROTARY NICKEL TITANIUM FILE 12/13/2006
K971319 TYCOM DENTAL NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILES 05/22/1997
K962031 TYCOM DENTAL QUANTEC SERIES 2000 ENDODONTIC FILES 06/04/1996


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