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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
Regulation Description Dental handpiece and accessories.
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
MICRO-NX CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
NAKANISHI INC.
  SUBSTANTIALLY EQUIVALENT 2
SAESHIN PRECISION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 71 71
2021 57 57
2022 31 31
2023 17 17
2024 14 14
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 102 102
Detachment of Device or Device Component 66 66
Output Problem 15 15
Therapeutic or Diagnostic Output Failure 9 9
Retraction Problem 8 8
Break 5 5
Incorrect Measurement 5 5
Calibration Problem 3 3
Temperature Problem 2 2
Device Displays Incorrect Message 2 2
Loss of Power 2 2
Loose or Intermittent Connection 2 2
Overheating of Device 2 2
Material Separation 2 2
Mechanics Altered 2 2
Battery Problem 2 2
Intermittent Energy Output 2 2
Physical Resistance/Sticking 2 2
Positioning Problem 1 1
Defective Device 1 1
Defective Component 1 1
Positioning Failure 1 1
Failure to Power Up 1 1
Use of Device Problem 1 1
Material Twisted/Bent 1 1
Device Damaged by Another Device 1 1
Vibration 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Insufficient Information 1 1
Computer Operating System Problem 1 1
Data Problem 1 1
Energy Output Problem 1 1
Unintended Electrical Shock 1 1
Failure to Auto Stop 1 1
Protective Measures Problem 1 1
Appropriate Term/Code Not Available 1 1
Display or Visual Feedback Problem 1 1
Electrical /Electronic Property Problem 1 1
Unexpected Shutdown 1 1
Device Slipped 1 1
Device Remains Activated 1 1
Fluid/Blood Leak 1 1
Failure to Charge 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 139 139
Insufficient Information 32 32
No Consequences Or Impact To Patient 25 25
No Known Impact Or Consequence To Patient 11 11
Device Embedded In Tissue or Plaque 5 5
No Information 4 4
Partial thickness (Second Degree) Burn 2 2
Full thickness (Third Degree) Burn 2 2
Electric Shock 1 1
No Code Available 1 1
Perforation 1 1
Paresthesia 1 1
Foreign Body In Patient 1 1
Nerve Damage 1 1
Pain 1 1
Tactile Disorders 1 1
Hemorrhage/Bleeding 1 1

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