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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 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
CEFLA S.C.
  SUBSTANTIALLY EQUIVALENT 3
DE GOTZEN S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
DENTIUM CO., LTD (ICT BRANCH)
  SUBSTANTIALLY EQUIVALENT 2
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
J.MORITA USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MIDMARK CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
OSSTEM IMPLANT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
PALODEX GROUP OY
  SUBSTANTIALLY EQUIVALENT 3
PLANMECA OY
  SUBSTANTIALLY EQUIVALENT 1
PLANMED OY
  SUBSTANTIALLY EQUIVALENT 2
PREXION CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
RAY CO., LTD
  SUBSTANTIALLY EQUIVALENT 4
RAY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
RAY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
TROPHY
  SUBSTANTIALLY EQUIVALENT 2
VATECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
VATECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VILLA SISTEMI MEDICALI S.P.A.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burning Sensation 1 1
Physical Entrapment 1 1
Radiation Exposure, Unintended 1 1

Recalls
Manufacturer Recall Class Date Posted
1 KaVo Dental Technologies LLC II Apr-22-2019
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