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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device x-ray, tomography, computed, dental
Definition Produce cross-sectional diagnostic x-ray images of the intra-oral tissue and teeth.
Product CodeOAS
Regulation Number 892.1750
Device Class 2


Premarket Reviews
ManufacturerDecision
ALLIAGE S/A INDUSTRIAS MEDICO ODONTOLÓGICA
  SUBSTANTIALLY EQUIVALENT 1
ALLIAGE S/A INDUSTRIAS MEDICO ODONTOLÓGICA.
  SUBSTANTIALLY EQUIVALENT 1
CEFLA S.C.
  SUBSTANTIALLY EQUIVALENT 4
DE GOTZEN S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
DENTIUM CO., LTD (ICT BRANCH)
  SUBSTANTIALLY EQUIVALENT 3
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 2
DURR DENTAL SE
  SUBSTANTIALLY EQUIVALENT 2
EPICA INTERNATIONAL INC.
  SUBSTANTIALLY EQUIVALENT 1
FONA S.R.L
  SUBSTANTIALLY EQUIVALENT 1
GENORAY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GENORAY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
HDX WILL CORP.
  SUBSTANTIALLY EQUIVALENT 2
J. MORITA USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEGAGEN IMPLANT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MIDMARK CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
OSSTEM IMPLANT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
PALODEX GROUP OY
  SUBSTANTIALLY EQUIVALENT 1
PLANMECA OY
  SUBSTANTIALLY EQUIVALENT 1
PLANMED OY
  SUBSTANTIALLY EQUIVALENT 1
PREXION CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
  1.  K190320  PreXion3D Explorer
  2.  K193329  PreXion3D Explorer EX
  3.  K203784  PreXion3D Explorer PRO
  4.  K221525  PreXion3D Explorer PRO
  5.  K222150  PreXion3D Expedition
  6.  K232166  PreXion3D Expedition
RAY CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
RAY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
TRIDENT S.R.L
  SUBSTANTIALLY EQUIVALENT 1
TROPHY
  SUBSTANTIALLY EQUIVALENT 1
VATECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 4
YIAN MEDICAL TECHNOLOGY (HAINING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2019 1 1
2022 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Power Conditioning Problem 1 1
Use of Device Problem 1 1
Noise, Audible 1 1
Radiation Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Arrhythmia 1 1
Fatigue 1 1
Burning Sensation 1 1
Physical Entrapment 1 1
Anxiety 1 1
Shaking/Tremors 1 1
Radiation Exposure, Unintended 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 KaVo Dental Technologies LLC II Apr-22-2019
2 Trophy SAS II May-27-2023
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