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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
META SYSTEMS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 163 163
2020 139 139
2021 107 107
2022 63 63
2023 56 56
2024 74 74

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Measurement 592 592
Incorrect, Inadequate or Imprecise Result or Readings 25 25
Output Problem 4 4
Mechanical Problem 3 3
Unintended Electrical Shock 2 2
Patient-Device Incompatibility 2 2
Therapeutic or Diagnostic Output Failure 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Break 1 1
No Display/Image 1 1
Communication or Transmission Problem 1 1
Device Markings/Labelling Problem 1 1
Insufficient Information 1 1
Defective Device 1 1
Material Perforation 1 1
Unexpected Therapeutic Results 1 1
Electrical /Electronic Property Problem 1 1
Device Displays Incorrect Message 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 355 355
No Consequences Or Impact To Patient 177 177
Insufficient Information 88 88
No Known Impact Or Consequence To Patient 58 58
No Information 43 43
Hypersensitivity/Allergic reaction 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Electric Shock 1 1
Injury 1 1
Irritation 1 1
Needle Stick/Puncture 1 1
Pain 1 1
Undesired Nerve Stimulation 1 1
Inadequate Pain Relief 1 1
Hemorrhage/Bleeding 1 1
Sensitivity of Teeth 1 1
Device Embedded In Tissue or Plaque 1 1

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