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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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New Search show TPLC since Back to Search Results
Device system, x-ray, extraoral source, digital
Product CodeMUH
Regulation Number 872.1800
Device Class 2


Premarket Reviews
ManufacturerDecision
3DISC AMERICAS
  SUBSTANTIALLY EQUIVALENT 1
AFP IMAGING CORP.
  SUBSTANTIALLY EQUIVALENT 1
AIR TECHNIQUES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ALLIAGE S/A INDUSTRIAS MEDICA ODONTOLÓGICO.
  SUBSTANTIALLY EQUIVALENT 1
APIXIA INC.
  SUBSTANTIALLY EQUIVALENT 1
ATHLOS OY
  SUBSTANTIALLY EQUIVALENT 1
CARESTREAM HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
CEFLA DENTAL GROUP
  SUBSTANTIALLY EQUIVALENT 2
CEFLA S.C.
  SUBSTANTIALLY EQUIVALENT 1
CEFLA S.C. CEFLA DENTAL GROUP
  SUBSTANTIALLY EQUIVALENT 1
CND GLOBAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
CRUXELL CORP.
  SUBSTANTIALLY EQUIVALENT 2
DE GOTZEN S.R.L
  SUBSTANTIALLY EQUIVALENT 1
DE GÖTZEN S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
DENTAL IMAGING TECHNOLOGIES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
DENTERPRISE INTERNATIONAL INC.
  SUBSTANTIALLY EQUIVALENT 1
DENTERPRISE INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
DENTIMAX
  SUBSTANTIALLY EQUIVALENT 1
DENTIMAX, INC
  SUBSTANTIALLY EQUIVALENT 1
DENTTIO, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEXCOWIN CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
DEXCOWIN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DEXIS LLC
  SUBSTANTIALLY EQUIVALENT 1
DUERR DENTAL AG
  SUBSTANTIALLY EQUIVALENT 1
DURR DENTAL SE
  SUBSTANTIALLY EQUIVALENT 2
DÜRR DENTAL SE
  SUBSTANTIALLY EQUIVALENT 1
E-WOO TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 1
EDLEN IMAGING LLC
  SUBSTANTIALLY EQUIVALENT 2
FONA S.R.L
  SUBSTANTIALLY EQUIVALENT 1
FONA SRL
  SUBSTANTIALLY EQUIVALENT 1
FSUSEN TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
GENORAY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 7
GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HDX WILL CORP.
  SUBSTANTIALLY EQUIVALENT 1
HEFEI DENTAFILM MEDICAL EQUIPMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTARIUM DENTAL, PALODEX GROUP OY
  SUBSTANTIALLY EQUIVALENT 3
IRAY IMAGING TECHNOLOGY (HAINING) LIMITED
  SUBSTANTIALLY EQUIVALENT 2
IRAY TECHNOLOGY TAICANG LTD.
  SUBSTANTIALLY EQUIVALENT 3
JAZZ IMAGING LLC
  SUBSTANTIALLY EQUIVALENT 1
JAZZ IMAGING LLC DBA JAZZ IMAGING
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU DYNAMIC MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KAVO DENTAL TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
MASTERLINK LLC
  SUBSTANTIALLY EQUIVALENT 1
MIC INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
MIDMARK
  SUBSTANTIALLY EQUIVALENT 1
MIDMARK CORP.
  SUBSTANTIALLY EQUIVALENT 2
NICAL SPA
  SUBSTANTIALLY EQUIVALENT 1
OWANDY
  SUBSTANTIALLY EQUIVALENT 2
PALODEX GROUP OY
  SUBSTANTIALLY EQUIVALENT 1
PANORAMIC CORP.
  SUBSTANTIALLY EQUIVALENT 2
PICOPACK INC.
  SUBSTANTIALLY EQUIVALENT 1
PLANMECA OY
  SUBSTANTIALLY EQUIVALENT 2
POINTNIX CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
QPIX SOLUTIONS INC.
  SUBSTANTIALLY EQUIVALENT 1
RAY CO., LTD
  SUBSTANTIALLY EQUIVALENT 4
RAY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
RAYENCE CO., LTD
  SUBSTANTIALLY EQUIVALENT 4
REALCLOUD IMAGING INC. DBA REALCLOUD IMAGING
  SUBSTANTIALLY EQUIVALENT 1
REMEDI CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
RF CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ROLENCE ENTERPRISE INC.
  SUBSTANTIALLY EQUIVALENT 1
SCHICK TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI HANDY MEDICAL EQUIPMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN XPECTVISION TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SODIUM SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SOPRO
  SUBSTANTIALLY EQUIVALENT 1
SOPRO - ACTEON GROUP
  SUBSTANTIALLY EQUIVALENT 3
SOTA PRECISION OPTICS, INC. DBA SOTA IMAGING
  SUBSTANTIALLY EQUIVALENT 1
SUNI MEDICAL IMAGING, INC
  SUBSTANTIALLY EQUIVALENT 1
TAKARA BELMONT CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
TAKARA BELMONT USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
TAKARA-BELMONT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TELEVERE SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
THE YOSHIDA DENTAL MFG. CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
TOSHIBA AMERICA ELECTRONIC COMPONENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TRIDENT S.R.L
  SUBSTANTIALLY EQUIVALENT 2
TRIDENT S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
TROPHY
  SUBSTANTIALLY EQUIVALENT 3
TUXEDO IMAGING LLC
  SUBSTANTIALLY EQUIVALENT 1
VATECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
VATECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
VILLA SISTEMI MEDICALI S.P.A.
  SUBSTANTIALLY EQUIVALENT 2
VIVI S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
ZUMA DENTAL, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 5 5
2015 3 3
2016 1 1
2017 4 4
2018 10 10
2019 6 6
2021 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operational Issue 10 10
Lack of Maintenance Documentation or Guidelines 3 3
Unintended Movement 2 2
Patient-Device Incompatibility 2 2
Connection Problem 2 2
Smoking 2 2
Arcing 2 2
Device Alarm System 2 2
Detachment Of Device Component 2 2
Electrical /Electronic Property Problem 2 2
Fire 2 2
Labelling, Instructions for Use or Training Problem 2 2
Loose or Intermittent Connection 1 1
Overheating of Device 1 1
Failure to Sense 1 1
Computer Software Problem 1 1
No Display/Image 1 1
Break 1 1
Defective Device 1 1
Sparking 1 1
Use of Device Problem 1 1
Component Missing 1 1
Device Operates Differently Than Expected 1 1
Electrical Shorting 1 1
Patient Data Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Naturally Worn 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Protective Measures Problem 1 1
Torn Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Radiation Exposure, Unintended 11 11
No Known Impact Or Consequence To Patient 6 6
No Patient Involvement 3 3
No Consequences Or Impact To Patient 3 3
Fatigue 2 2
Tinnitus 2 2
Cramp(s) 1 1
Dizziness 1 1
No Information 1 1
Cancer 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Headache 1 1
Pain 1 1
Arrhythmia 1 1
Burn(s) 1 1
Diarrhea 1 1
Radiation Sickness Syndrome 1 1
Anxiety 1 1
Neck Pain 1 1
Shaking/Tremors 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Carestream Health, Inc. II Apr-03-2015
2 Gendex Dental Systems II Jul-17-2009
3 Imaging Sciences International, LLC II May-22-2009
4 KaVo Dental Technologies LLC II May-21-2019
5 Midmark Corp dba Progeny Inc II Jan-25-2016
6 Midmark Corp dba Progeny Inc II Jan-09-2014
7 Villa Radiology Systems LLC II Nov-06-2015
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