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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 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 2
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
2021 79 79
2022 37 37
2023 14 14
2024 19 19
2025 9 9
2026 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 85 85
Mechanical Problem 71 71
Output Problem 15 15
Physical Resistance/Sticking 13 13
Overheating of Device 12 12
Break 11 11
Defective Device 10 10
Device Handling Problem 7 7
Unintended Electrical Shock 4 4
Energy Output Problem 4 4
Device Slipped 3 3
Therapeutic or Diagnostic Output Failure 3 3
Dent in Material 3 3
Device Fell 2 2
Failure to Align 2 2
Mechanics Altered 2 2
Leak/Splash 1 1
Fire 1 1
Insufficient Information 1 1
Positioning Problem 1 1
No Audible Alarm 1 1
Use of Device Problem 1 1
Explosion 1 1
Protective Measures Problem 1 1
Appropriate Term/Code Not Available 1 1
No Device Output 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 147 147
Insufficient Information 16 16
Burn(s) 11 11
Hemorrhage/Bleeding 2 2
Electric Shock 1 1
Foreign Body In Patient 1 1
Vomiting 1 1
Swelling/ Edema 1 1

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