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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
CHANGZHOU BOMEDENT MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHANGZHOU SIFARY MEDICAL TECHNOLOGY 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
SAESHIN PRECISION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SAEYANG MICROTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN PERFECT MEDICAL INSTRUMENTS 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 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 121 121
Mechanical Problem 87 87
Defective Device 25 25
Physical Resistance/Sticking 15 15
Overheating of Device 15 15
Output Problem 14 14
Computer Operating System Problem 12 12
Break 12 12
Therapeutic or Diagnostic Output Failure 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
Protective Measures Problem 2 2
Positioning Problem 2 2
Device Fell 2 2
Failure to Align 2 2
Data Problem 2 2
Mechanics Altered 2 2
Leak/Splash 1 1
No Audible Alarm 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Appropriate Term/Code Not Available 1 1
Device Displays Incorrect Message 1 1
Use of Device Problem 1 1
Loose or Intermittent Connection 1 1
Failure to Shut Off 1 1
Insufficient Information 1 1
No Device Output 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 175 175
No Consequences Or Impact To Patient 45 45
Insufficient Information 20 20
No Known Impact Or Consequence To Patient 16 16
Burn(s) 11 11
Electric Shock 3 3
Burn, Thermal 2 2
No Information 2 2
Hemorrhage/Bleeding 2 2
Vomiting 1 1
Swelling/ Edema 1 1
Device Embedded In Tissue or Plaque 1 1

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