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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 3
PALODEX GROUP OY
  SUBSTANTIALLY EQUIVALENT 2
PLANMECA OY
  SUBSTANTIALLY EQUIVALENT 1
PLANMED OY
  SUBSTANTIALLY EQUIVALENT 1
PREXION CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
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
2024 2 2

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

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

Recalls
Manufacturer Recall Class Date Posted
1 KaVo Dental Technologies LLC II Apr-22-2019
2 Palodex Group Oy II Aug-12-2024
3 Trophy SAS II May-27-2023
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