Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 57 57

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Measurement 575 575
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
Unexpected Therapeutic Results 1 1
Device Markings/Labelling Problem 1 1
Insufficient Information 1 1
Defective Device 1 1
Material Perforation 1 1
No Display/Image 1 1
Break 1 1
Communication or Transmission Problem 1 1
Device Displays Incorrect Message 1 1
Electrical /Electronic Property Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 344 344
No Consequences Or Impact To Patient 177 177
Insufficient Information 80 80
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

-
-