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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device controller, foot, handpiece and cord
Product CodeEBW
Regulation Number 872.4200
Device Class 1


Premarket Reviews
ManufacturerDecision
CEFLA S.C.
  SUBSTANTIALLY EQUIVALENT 2
CODENT TECHNICAL INDUSTRY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DENTIUM CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
FOSHAN CICADA DENTAL INSTRUMENT CO, LTD.
  SUBSTANTIALLY EQUIVALENT 1
FOSHAN COXO MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
HANDPIECE HEADQUARTERS - HPR INC.
  SUBSTANTIALLY EQUIVALENT 1
MICRO-NX CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SAESHIN PRECISION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
W&H DENTALWERK BUERMOOS GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 55 55
2020 71 71
2021 57 57
2022 31 31
2023 17 17
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 105 105
Detachment of Device or Device Component 85 85
Retraction Problem 21 21
Output Problem 15 15
Therapeutic or Diagnostic Output Failure 11 11
Break 10 10
Loose or Intermittent Connection 6 6
Defective Device 6 6
Calibration Problem 5 5
Device Damaged by Another Device 5 5
Incorrect Measurement 5 5
Loss of Power 3 3
Device Displays Incorrect Message 3 3
Battery Problem 2 2
Inappropriate or Unexpected Reset 2 2
Mechanics Altered 2 2
Power Conditioning Problem 2 2
Defective Component 2 2
Material Separation 2 2
Device Slipped 2 2
Energy Output Problem 2 2
Physical Resistance/Sticking 2 2
Unexpected Shutdown 2 2
Intermittent Energy Output 2 2
Temperature Problem 2 2
Unintended Electrical Shock 1 1
Overheating of Device 1 1
Failure to Charge 1 1
Use of Incorrect Control/Treatment Settings 1 1
Positioning Failure 1 1
Display or Visual Feedback Problem 1 1
Electrical /Electronic Property Problem 1 1
Fluid/Blood Leak 1 1
Use of Device Problem 1 1
Vibration 1 1
Failure to Power Up 1 1
Device Remains Activated 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Positioning Problem 1 1
Protective Measures Problem 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Data Problem 1 1
Material Twisted/Bent 1 1
Mechanical Jam 1 1
Failure to Auto Stop 1 1
Computer Operating System Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 133 133
No Consequences Or Impact To Patient 67 67
Insufficient Information 28 28
No Known Impact Or Consequence To Patient 25 25
No Information 16 16
Device Embedded In Tissue or Plaque 6 6
Foreign Body In Patient 2 2
Full thickness (Third Degree) Burn 2 2
Electric Shock 1 1
Hemorrhage/Bleeding 1 1
Pain 1 1
Perforation 1 1
No Code Available 1 1
Tactile Disorders 1 1
Paresthesia 1 1

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