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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device handpiece, contra- and right-angle attachment, dental
Regulation Description Dental handpiece and accessories.
Product CodeEGS
Regulation Number 872.4200
Device Class 1


Premarket Reviews
ManufacturerDecision
BONART CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DENTALEZ, INC
  SUBSTANTIALLY EQUIVALENT 1
KAVO DENTAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
NAKANISHI INC.
  SUBSTANTIALLY EQUIVALENT 2
SAESHIN PRECISION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2017 316 316
2018 230 230
2019 219 219
2020 191 191
2021 275 275

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 732 732
Detachment of Device or Device Component 352 352
Temperature Problem 164 164
Mechanical Problem 100 100
Detachment Of Device Component 56 56
Dent in Material 54 54
Therapeutic or Diagnostic Output Failure 41 41
Defective Device 32 32
Physical Resistance/Sticking 27 27
Loose or Intermittent Connection 26 26
Failure To Service 22 22
Device Handling Problem 16 16
Output Problem 16 16
Break 12 12
Computer Operating System Problem 10 10
Improper or Incorrect Procedure or Method 10 10
Noise, Audible 10 10
Device Maintenance Issue 8 8
Use of Device Problem 7 7
Physical Property Issue 7 7
Retraction Problem 6 6
Incorrect Measurement 5 5
Appropriate Term/Code Not Available 5 5
Data Problem 5 5
Device Operates Differently Than Expected 3 3
Device Dislodged or Dislocated 3 3
Entrapment of Device 3 3
Material Separation 3 3
Defective Component 3 3
Calibration Problem 3 3
Failure to Align 2 2
Fitting Problem 2 2
Component Falling 2 2
Loss of Power 2 2
Device Damaged by Another Device 2 2
Unintended Movement 2 2
Insufficient Information 2 2
Device Fell 2 2
Unintended Electrical Shock 1 1
Unexpected Shutdown 1 1
Excessive Heating 1 1
Human Factors Issue 1 1
Inappropriate or Unexpected Reset 1 1
Material Deformation 1 1
Mechanical Jam 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Misconnection 1 1
Device Slipped 1 1
Smoking 1 1
Device Inoperable 1 1
Computer Software Problem 1 1
Crack 1 1
Failure to Cycle 1 1
Unintended Ejection 1 1
Fluid Leak 1 1
Component Missing 1 1
Device Issue 1 1
Vibration 1 1
Device Displays Incorrect Message 1 1
Malposition of Device 1 1
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 481 481
Burn(s) 260 260
No Clinical Signs, Symptoms or Conditions 248 248
Burn, Thermal 202 202
Patient Problem/Medical Problem 156 156
Injury 145 145
No Known Impact Or Consequence To Patient 102 102
Partial thickness (Second Degree) Burn 46 46
Insufficient Information 42 42
Superficial (First Degree) Burn 22 22
Foreign Body In Patient 19 19
No Information 14 14
Pain 12 12
Burning Sensation 5 5
No Code Available 4 4
Full thickness (Third Degree) Burn 4 4
Laceration(s) 4 4
Swelling 3 3
Erosion 2 2
Tooth Fracture 2 2
Skin Tears 2 2
Skin Burning Sensation 2 2
Unspecified Tissue Injury 1 1
Swelling/ Edema 1 1
Blister 1 1
Electric Shock 1 1
No Patient Involvement 1 1
Numbness 1 1
Complaint, Ill-Defined 1 1
Hemorrhage/Bleeding 1 1
Ulceration 1 1
Perforation 1 1
Scar Tissue 1 1

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