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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
ADVANCED TECHNOLOGY RESEARCH (A.T.R.) S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
CHANGZHOU BOMEDENT MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K191276  Dental Electrical Motor iRoot Pro
CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DENTIS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY SIRONA INC.
  SUBSTANTIALLY EQUIVALENT 1
FORUM ENGINEERING TECHNOLOGIES (96) LTD.
  SUBSTANTIALLY EQUIVALENT 1
FOSHAN CICADA DENTAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FOSHAN COXO MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GENOSS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
HANDPIECE HEADQUARTERS
  SUBSTANTIALLY EQUIVALENT 1
META SYSTEMS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
MICRO-NX CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PERIMETRICS, INC
  SUBSTANTIALLY EQUIVALENT 1
PERIMETRICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SAESHIN PRECISION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SAEYANG MICROTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN PERFECT MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN ROGIN MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
W&H DENTALWERK BUERMOOS GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 67 67
2021 79 79
2022 37 37
2023 14 14
2024 19 19
2025 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 122 122
Mechanical Problem 92 92
Defective Device 25 25
Output Problem 15 15
Physical Resistance/Sticking 15 15
Overheating of Device 15 15
Break 12 12
Therapeutic or Diagnostic Output Failure 12 12
Computer Operating System Problem 12 12
Device Handling Problem 7 7
Unintended Electrical Shock 6 6
Self-Activation or Keying 5 5
Energy Output Problem 4 4
Dent in Material 4 4
Device Slipped 3 3
Device Fell 2 2
Positioning Problem 2 2
Failure to Align 2 2
Mechanics Altered 2 2
Data Problem 2 2
Protective Measures Problem 2 2
Leak/Splash 1 1
Failure to Shut Off 1 1
Fire 1 1
Insufficient Information 1 1
No Audible Alarm 1 1
Use of Device Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Explosion 1 1
Appropriate Term/Code Not Available 1 1
Loose or Intermittent Connection 1 1
Device Displays Incorrect Message 1 1
No Device Output 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 182 182
No Consequences Or Impact To Patient 45 45
Insufficient Information 21 21
No Known Impact Or Consequence To Patient 16 16
Burn(s) 11 11
Electric Shock 3 3
No Information 2 2
Burn, Thermal 2 2
Hemorrhage/Bleeding 2 2
Foreign Body In Patient 1 1
Vomiting 1 1
Swelling/ Edema 1 1
Device Embedded In Tissue or Plaque 1 1

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