FDA 510(k) Applications for Medical Device Product Code "EAP"
(Unit, X-Ray, Intraoral)

FDA 510(k) Number Applicant Device Name Decision Date
K102573 ADVANCED IMAGE SCIENCE, INC. PROVU (TM) DENTAL X-RAY SYSTEM 06/30/2011
K080738 DENTRON SYSTEMS LLC DENTRON SENSOR 05/13/2008
K960028 DENTSPLY INTL. ORTHORALIX SD2 & S PANORAMIC DENTAL X-RAY SYSTEM 03/01/1996
K052422 FLOW X-RAY CORP. THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE) 09/27/2005
K113360 HUMANRAY CO,LTD MEDICAL IMAGE PROCESSING UNIT 02/07/2012
K960819 PELTON & CRANE CO. HELIODENT DS 03/29/1996
K041385 SCHICK TECHNOLOGIES, INC. MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM 06/07/2004
K093453 SCHICK TECHNOLOGIES, INC. MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM 11/30/2009


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