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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
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
CEFLA S.C.
  SUBSTANTIALLY EQUIVALENT 1
DENTERPRISE INTERNATIONAL, INC
  SUBSTANTIALLY EQUIVALENT 1
DIGIMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DIGIMED CO., LTD. (DIGIMED CORPORATION UNTIL 31/12/2012)
  SUBSTANTIALLY EQUIVALENT 1
GENORAY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HDX WILL CORP.
  SUBSTANTIALLY EQUIVALENT 2
RADIOTECNOLOGIA INDUSTRIAL S.A. DE C.V.
  SUBSTANTIALLY EQUIVALENT 1
SKANRAY TECHNOLOGIES PVT LTD
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Battery Problem 91
Migration or Expulsion of Device 37
Device Operational Issue 17
Unintended Movement 7
Maintenance Does Not Comply To Manufacturers Recommendations 6
Detachment Of Device Component 5
Mechanical Problem 5
Insufficient Information 4
Device Dislodged or Dislocated 4
Break 3
Melted 3
Installation-Related Problem 3
Component Falling 2
Device Handling Problem 2
Device Maintenance Issue 2
Thermal Decomposition of Device 2
Detachment of Device or Device Component 2
Adverse Event Without Identified Device or Use Problem 2
Misassembly by Users 1
Device Emits Odor 1
Unstable 1
Device Displays Incorrect Message 1
Overheating of Device 1
Device Slipped 1
Temperature Problem 1
Handpiece 1
Radiation Output Problem 1
Fire 1
Device Fell 1
Device Issue 1
Unintended System Motion 1
Device Operates Differently Than Expected 1
Human Factors Issue 1
Improper Device Output 1
Power Problem 1
Radiation Overexposure 1
Total Device Problems 215

Recalls
Manufacturer Recall Class Date Posted
1 Aribex Inc II Sep-02-2016
2 Panoramic Rental Corp. II Jan-09-2018
3 Panoramic Rental Corp. II Oct-04-2016
4 Panoramic Rental Corp. II Sep-01-2015

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