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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
SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K242765  Electronic Apex Locator (Alpha Apex I)

MDR Year MDR Reports MDR Events
2019 163 163
2020 139 139
2021 107 107
2022 63 63
2023 56 56
2024 81 81
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Measurement 602 602
Incorrect, Inadequate or Imprecise Result or Readings 25 25
Output Problem 4 4
Mechanical Problem 3 3
Unintended Electrical Shock 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Patient-Device Incompatibility 2 2
Therapeutic or Diagnostic Output Failure 2 2
Unexpected Therapeutic Results 1 1
Device Markings/Labelling Problem 1 1
Communication or Transmission Problem 1 1
Material Perforation 1 1
Device Displays Incorrect Message 1 1
Break 1 1
Electrical /Electronic Property Problem 1 1
Insufficient Information 1 1
No Display/Image 1 1
Defective Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 366 366
No Consequences Or Impact To Patient 177 177
Insufficient Information 91 91
No Known Impact Or Consequence To Patient 58 58
No Information 43 43
Pain 2 2
Hypersensitivity/Allergic reaction 2 2
Device Embedded In Tissue or Plaque 1 1
Hemorrhage/Bleeding 1 1
Undesired Nerve Stimulation 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Needle Stick/Puncture 1 1
Inadequate Pain Relief 1 1
Injury 1 1
Sensitivity of Teeth 1 1
Electric Shock 1 1
Irritation 1 1

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