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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device unit, x-ray, extraoral with timer
Regulation Description Extraoral source x-ray system.
Product CodeEHD
Regulation Number 872.1800
Device Class 2


Premarket Reviews
ManufacturerDecision
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 4
DENTSPLY TULSA DENTAL SPECIALTIES
  SUBSTANTIALLY EQUIVALENT 1
EASTMAN KODAK
  SUBSTANTIALLY EQUIVALENT 2
FISHER & PAYKEL HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 2
GENDEX
  SUBSTANTIALLY EQUIVALENT 1
KAVO
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL DEVICE CONSULTANTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
Minxray Inc
  SUBSTANTIALLY EQUIVALENT 2
PROGENY, INC.
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS
  SUBSTANTIALLY EQUIVALENT 2
TROPHY
  SUBSTANTIALLY EQUIVALENT 6

Device Problems
Detachment of device component 3
Self-activation or keying 2
Device inoperable 2
Device operates differently than expected 2
Material separation 1
Component falling 1
Failure to power-up 1
Break 1
Component(s), broken 1
Total Device Problems 14

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 0 4 1 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Gendex Dental Systems II Apr-02-2012
2 Gendex Dental Systems II Apr-22-2011
3 Gendex Dental Systems II Mar-04-2011
4 Gendex Dental Systems II Feb-18-2011
5 Gendex Dental Systems II Feb-15-2011

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