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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
DENTALEZ, INC., STARDENTAL DIVISION
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY SIRONA, INC.
  SUBSTANTIALLY EQUIVALENT 1
FOSHAN CICADA DENTAL INSTRUMENT CO, LTD.
  SUBSTANTIALLY EQUIVALENT 1
FOSHAN COXO MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUILIN AESTHEDENT MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
MICRO-NX CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
NAKANISHI, INC.
  SUBSTANTIALLY EQUIVALENT 2
SAESHIN PRECISION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 57 57
2022 31 31
2023 17 17
2024 14 14
2025 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 75 75
Detachment of Device or Device Component 40 40
Output Problem 15 15
Therapeutic or Diagnostic Output Failure 4 4
Incorrect Measurement 4 4
Overheating of Device 4 4
Physical Resistance/Sticking 2 2
Intermittent Energy Output 2 2
Battery Problem 2 2
Mechanics Altered 2 2
Device Displays Incorrect Message 2 2
Temperature Problem 2 2
Failure to Charge 1 1
Unexpected Shutdown 1 1
Unintended Electrical Shock 1 1
Energy Output Problem 1 1
Insufficient Information 1 1
Vibration 1 1
Defective Component 1 1
Positioning Problem 1 1
Positioning Failure 1 1
Failure to Power Up 1 1
Use of Device Problem 1 1
Material Twisted/Bent 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Calibration Problem 1 1
Appropriate Term/Code Not Available 1 1
Display or Visual Feedback Problem 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 110 110
Insufficient Information 27 27
Burn(s) 2 2
Partial thickness (Second Degree) Burn 2 2
Full thickness (Third Degree) Burn 2 2
Electric Shock 1 1
Perforation 1 1
Paresthesia 1 1
Nerve Damage 1 1
Pain 1 1
Tactile Disorders 1 1
Hemorrhage/Bleeding 1 1

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