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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device locator, root apex
Product CodeLQY
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
CEFLA S.C.
  SUBSTANTIALLY EQUIVALENT 1
CHANGZHOU BOMEDENT MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
CHANGZHOU HAILI MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 1
FOSHAN COXO MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GOOD DOCTORS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
META SYSTEMS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 154 154
2019 163 163
2020 139 139
2021 107 107
2022 63 63
2023 56 56
2024 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Measurement 683 683
Incorrect, Inadequate or Imprecise Result or Readings 26 26
Output Problem 4 4
Patient-Device Incompatibility 3 3
Mechanical Problem 3 3
No Display/Image 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Unintended Electrical Shock 2 2
Insufficient Information 1 1
Break 1 1
Communication or Transmission Problem 1 1
Device Markings/Labelling Problem 1 1
Electrical /Electronic Property Problem 1 1
Overheating of Device 1 1
Unexpected Therapeutic Results 1 1
Material Perforation 1 1
Defective Device 1 1
Device Displays Incorrect Message 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 310 310
No Clinical Signs, Symptoms or Conditions 301 301
No Known Impact Or Consequence To Patient 85 85
Insufficient Information 75 75
No Information 71 71
Hypersensitivity/Allergic reaction 3 3
Irritation 1 1
Undesired Nerve Stimulation 1 1
Device Embedded In Tissue or Plaque 1 1
Injury 1 1
Inadequate Pain Relief 1 1
Sensitivity of Teeth 1 1
Needle Stick/Puncture 1 1
Electric Shock 1 1
Hemorrhage/Bleeding 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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