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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device handpiece, direct drive, ac-powered
Regulation Description Dental handpiece and accessories.
Product CodeEKX
Regulation Number 872.4200
Device Class 1


Premarket Reviews
ManufacturerDecision
ASEPTICO, INC.
  SUBSTANTIALLY EQUIVALENT 1
J. MORITA CORP.
  SUBSTANTIALLY EQUIVALENT 2
MICRO-NX CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
OSSTELL AB
  SUBSTANTIALLY EQUIVALENT 2
SAESHIN PRECISION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 68 68
2016 66 66
2017 10 10
2018 49 49
2019 56 56
2020 63 63

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 124 124
Detachment of Device or Device Component 54 54
Mechanical Problem 45 45
Retraction Problem 40 40
Device Operates Differently Than Expected 26 26
Unintended Movement 24 24
Self-Activation or Keying 23 23
Defective Device 22 22
Dent in Material 19 19
Computer Operating System Problem 17 17
Therapeutic or Diagnostic Output Failure 14 14
Motor(s) 13 13
Inappropriate/Inadequate Shock/Stimulation 7 7
Failure to Calibrate 6 6
Temperature Problem 6 6
Break 6 6
Device Damaged by Another Device 5 5
Loose or Intermittent Connection 5 5
Handpiece 5 5
Device Maintenance Issue 4 4
Foot Pedal 4 4
Improper or Incorrect Procedure or Method 4 4
Failure To Service 4 4
Material Separation 4 4
Device Handling Problem 3 3
Insufficient Information 2 2
Appropriate Term/Code Not Available 2 2
Calibration Problem 2 2
Fluid Leak 2 2
Electrical /Electronic Property Problem 2 2
Physical Resistance/Sticking 2 2
Loss of Data 2 2
Mechanics Altered 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Positioning Problem 1 1
Fail-Safe Problem 1 1
Inappropriate or Unexpected Reset 1 1
Data Problem 1 1
Leak/Splash 1 1
Energy Output Problem 1 1
Detachment Of Device Component 1 1
Component Falling 1 1
Device Displays Incorrect Message 1 1
Fitting Problem 1 1
Defective Component 1 1
Failure to Advance 1 1
Unintended Electrical Shock 1 1
Device Issue 1 1
Display or Visual Feedback Problem 1 1
Brush 1 1
Current Source 1 1
Failure to Auto Stop 1 1
Failure to Shut Off 1 1
Maintenance Does Not Comply To Manufacturers Recommendations 1 1
Output Problem 1 1
Protective Measures Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 188 188
Burn, Thermal 69 69
No Known Impact Or Consequence To Patient 68 68
No Clinical Signs, Symptoms or Conditions 29 29
No Information 17 17
Electric Shock 8 8
Burn(s) 4 4
Insufficient Information 3 3
No Patient Involvement 3 3
Shock 2 2
Choking 1 1
Blood Loss 1 1
Foreign Body In Patient 1 1
Patient Problem/Medical Problem 1 1
Not Applicable 1 1
Partial thickness (Second Degree) Burn 1 1

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