EAP — Unit, X-Ray, Intraoral Class II

FDA Device Classification

Classification Details

Product Code
EAP
Device Class
Class II
Regulation Number
872.1810
Submission Type
Review Panel
RA
Medical Specialty
Dental
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K113360humanray coMEDICAL IMAGE PROCESSING UNITFebruary 7, 2012
K102573advanced image sciencePROVU (TM) DENTAL X-RAY SYSTEMJune 30, 2011
K093453schick technologiesMODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEMNovember 30, 2009
K080738dentron systemsDENTRON SENSORMay 13, 2008
K052422flow x-rayTHE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE)September 27, 2005
K041385schick technologiesMODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEMJune 7, 2004
K960819pelton and craneHELIODENT DSMarch 29, 1996
K960028dentsply intlORTHORALIX SD2 & S PANORAMIC DENTAL X-RAY SYSTEMMarch 1, 1996
K953936trophy radiologieATLANTISDecember 28, 1995
K954565chicago x-ray systemsEXPLOR-X (AZTEH) HFOctober 27, 1995
K951734emix u.s.aLUMIX 70BJuly 20, 1995
K950533trophy radiologieTROPHY RADIOLOGIE RVG RADIOVISIOGRAPHYJune 30, 1995
K950532trophy radiologieTROPHY RADIOLOGIE RVG PORTABLE RADIOVISIOGRAPHYApril 19, 1995
K950667chicago x-ray systemsAZTECH 65 WITH CCD (COMPUTER CONTROLLED DENSITY) TIMERApril 6, 1995
K950030pelton and craneHELIODENT MDFebruary 3, 1995
K934645radworksRADWORKSAugust 17, 1994
K936068pelton and craneORTHOPHOS 3/ ORTHOPHOS 3CJuly 29, 1994
K933455schick technologiesCOMPUTED ORAL RADIOLOGY SYSTEMJanuary 31, 1994
K931486keystone x-rayINTREX VSK INTERORAL DENTAL X-RAY UNITNovember 23, 1993
K931717kaycor intlYOSHIDA/KAYCOR X-707 WALL MOUNTED DENTAL X-RAYSeptember 20, 1993