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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 INTERNATIONAL INC.
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 1
FORUM ENGINEERING TECHNOLOGIES (96) LTD.
  SUBSTANTIALLY EQUIVALENT 1
FORUM ENGINEERING TECHNOLOGIES LTD
  SUBSTANTIALLY EQUIVALENT 1
FOSHAN COXO MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GOOD DOCTORS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GOOD DOCTORS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
J. MORITA USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICNRG LTD.
  SUBSTANTIALLY EQUIVALENT 1
META SYSTEMS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MICRO-MEGA SOCIETE ANONYME
  SUBSTANTIALLY EQUIVALENT 1
ROMIDAN LTD
  SUBSTANTIALLY EQUIVALENT 1
S-DENTI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2015 59 59
2016 128 128
2017 133 133
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 996 996
Incorrect, Inadequate or Imprecise Result or Readings 34 34
Device Operates Differently Than Expected 7 7
Output Problem 4 4
Mechanical Problem 3 3
False Reading From Device Non-Compliance 3 3
Improper Device Output 3 3
Measurement System Incompatibility 3 3
Patient-Device Incompatibility 3 3
Adverse Event Without Identified Device or Use Problem 2 2
No Display/Image 2 2
Unintended Electrical Shock 2 2
Overheating of Device 2 2
Therapeutic or Diagnostic Output Failure 2 2
Insufficient Information 1 1
Electrical /Electronic Property Problem 1 1
Break 1 1
Component Falling 1 1
Unexpected Therapeutic Results 1 1
Material Perforation 1 1
Defective Device 1 1
Device Displays Incorrect Message 1 1
Application Program Version or Upgrade Problem 1 1
Communication or Transmission Problem 1 1
Device Markings/Labelling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 561 561
No Clinical Signs, Symptoms or Conditions 301 301
No Known Impact Or Consequence To Patient 150 150
No Information 131 131
Insufficient Information 75 75
Injury 7 7
Hemorrhage/Bleeding 4 4
Hypersensitivity/Allergic reaction 3 3
Perforation 3 3
No Patient Involvement 3 3
Pain 2 2
Complaint, Ill-Defined 1 1
Irritation 1 1
Undesired Nerve Stimulation 1 1
Inadequate Pain Relief 1 1
Sensitivity of Teeth 1 1
Needle Stick/Puncture 1 1
Electric Shock 1 1
No Code Available 1 1
Device Embedded In Tissue or Plaque 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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