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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
MICRO-NX CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
OSSTELL AB
  SUBSTANTIALLY EQUIVALENT 1
PREMIER DENTAL COMPANY PRODUCTS
  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 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 128 128
Mechanical Problem 71 71
Retraction Problem 34 34
Defective Device 32 32
Overheating of Device 26 26
Unintended Movement 24 24
Self-Activation or Keying 22 22
Device Operates Differently Than Expected 18 18
Therapeutic or Diagnostic Output Failure 18 18
Computer Operating System Problem 17 17
Break 15 15
Output Problem 13 13
Physical Resistance/Sticking 7 7
Unintended Electrical Shock 6 6
Loose or Intermittent Connection 5 5
Device Maintenance Issue 4 4
Failure To Service 3 3
Inappropriate/Inadequate Shock/Stimulation 3 3
Improper or Incorrect Procedure or Method 3 3
Dent in Material 3 3
Failure to Align 2 2
Device Damaged by Another Device 2 2
Positioning Problem 2 2
Loss of Data 2 2
Mechanics Altered 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Device Fell 2 2
Data Problem 2 2
Device Handling Problem 2 2
Protective Measures Problem 1 1
Appropriate Term/Code Not Available 1 1
Failure to Auto Stop 1 1
Failure to Shut Off 1 1
Inappropriate or Unexpected Reset 1 1
Device Displays Incorrect Message 1 1
Calibration Problem 1 1
Fitting Problem 1 1
Defective Component 1 1
Failure to Calibrate 1 1
Use of Device Problem 1 1
Material Separation 1 1
Leak/Splash 1 1
No Audible Alarm 1 1
Energy Output Problem 1 1
No Device Output 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 131 131
No Clinical Signs, Symptoms or Conditions 122 122
No Known Impact Or Consequence To Patient 49 49
Burn, Thermal 19 19
Insufficient Information 17 17
No Information 12 12
Electric Shock 6 6
Burn(s) 5 5
Shock 2 2
Vomiting 1 1
Device Embedded In Tissue or Plaque 1 1
No Patient Involvement 1 1

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