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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device handpiece, direct drive, ac-powered
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
DMS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FOSHAN CICADA DENTAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
HIOSSEN, INC.
  SUBSTANTIALLY EQUIVALENT 1
J. MORITA USA, INC.
  SUBSTANTIALLY EQUIVALENT 2
META SYSTEMS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
MICRO-NX CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
OSSTELL AB
  SUBSTANTIALLY EQUIVALENT 1
PREMIER DENTAL COMPANY PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
SAESHIN PRECISION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SAEYANG MICROTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
W&H DENTALWERK BUERMOOS GMBH
  SUBSTANTIALLY EQUIVALENT 1
YOUNG DENTAL MANUFACTURING CO 1, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 10 10
2018 49 49
2019 56 56
2020 67 67
2021 79 79
2022 35 35

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 141 141
Mechanical Problem 79 79
Retraction Problem 34 34
Overheating of Device 32 32
Defective Device 32 32
Unintended Movement 24 24
Self-Activation or Keying 22 22
Therapeutic or Diagnostic Output Failure 18 18
Device Operates Differently Than Expected 18 18
Computer Operating System Problem 17 17
Break 16 16
Output Problem 15 15
Physical Resistance/Sticking 14 14
Device Handling Problem 7 7
Unintended Electrical Shock 6 6
Dent in Material 5 5
Loose or Intermittent Connection 5 5
Mechanics Altered 4 4
Device Maintenance Issue 4 4
Energy Output Problem 4 4
Failure To Service 3 3
Inappropriate/Inadequate Shock/Stimulation 3 3
Improper or Incorrect Procedure or Method 3 3
Device Slipped 3 3
Failure to Align 2 2
Appropriate Term/Code Not Available 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Positioning Problem 2 2
Loss of Data 2 2
Data Problem 2 2
Device Fell 2 2
Device Damaged by Another Device 2 2
Protective Measures Problem 2 2
Material Separation 1 1
Leak/Splash 1 1
Fitting Problem 1 1
Defective Component 1 1
Device Displays Incorrect Message 1 1
Inappropriate or Unexpected Reset 1 1
Calibration Problem 1 1
Insufficient Information 1 1
Failure to Auto Stop 1 1
Failure to Shut Off 1 1
Use of Device Problem 1 1
Failure to Calibrate 1 1
No Audible Alarm 1 1
No Device Output 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 143 143
No Consequences Or Impact To Patient 131 131
No Known Impact Or Consequence To Patient 49 49
Burn, Thermal 19 19
Insufficient Information 18 18
No Information 12 12
Burn(s) 10 10
Electric Shock 6 6
Shock 2 2
Hemorrhage/Bleeding 1 1
No Patient Involvement 1 1
Device Embedded In Tissue or Plaque 1 1
Vomiting 1 1

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