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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 system, x-ray, extraoral source, digital
Regulation Description Extraoral source x-ray system.
Product CodeMUH
Regulation Number 872.1800
Device Class 2


Premarket Reviews
ManufacturerDecision
CARESTREAM DENTAL LLC
  SUBSTANTIALLY EQUIVALENT 1
CEFLA S.C.
  SUBSTANTIALLY EQUIVALENT 1
DENTERPRISE INTERNATIONAL, INC
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 1
DENTTIO, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEXCOWIN CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
DEXCOWIN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DUERR DENTAL AG
  SUBSTANTIALLY EQUIVALENT 1
EDLEN IMAGING LLC
  SUBSTANTIALLY EQUIVALENT 1
GENORAY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HDX WILL CORP.
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTARIUM DENTAL, PALODEX GROUP OY
  SUBSTANTIALLY EQUIVALENT 1
KAVO DENTAL TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
NICAL SPA
  SUBSTANTIALLY EQUIVALENT 1
OWANDY
  SUBSTANTIALLY EQUIVALENT 1
PALODEX GROUP OY
  SUBSTANTIALLY EQUIVALENT 1
PANORAMIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
RAY CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
RAYENCE CO., LTD
  SUBSTANTIALLY EQUIVALENT 4
SOPRO - ACTEON GROUP
  SUBSTANTIALLY EQUIVALENT 3
TAKARA BELMONT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
THE YOSHIDA DENTAL MFG. CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TROPHY
  SUBSTANTIALLY EQUIVALENT 1
VILLA SISTEMI MEDICALI S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
ZUMA DENTAL, LLC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device Operational Issue 10
Lack of Maintenance Documentation or Guidelines 3
Device Alarm System 2
Arcing 2
Fire 2
Electrical /Electronic Property Problem 2
Adverse Event Without Identified Device or Use Problem 1
Smoking 1
Patient Data Problem 1
Computer Software Problem 1
Scanner 1
Labelling, Instructions for Use or Training Problem 1
Total Device Problems 27

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

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