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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device controller, foot, handpiece and cord
Product CodeEBW
Regulation Number 872.4200
Device Class 1


Premarket Reviews
ManufacturerDecision
CEFLA S.C.
  SUBSTANTIALLY EQUIVALENT 1
DENTIUM CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 1
FOSHAN CICADA DENTAL INSTRUMENT CO, LTD.
  SUBSTANTIALLY EQUIVALENT 1
FOSHAN COXO MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
HANDPIECE HEADQUARTERS - HPR INC.
  SUBSTANTIALLY EQUIVALENT 1
KALTENBACH & VOIGT GMGH
  SUBSTANTIALLY EQUIVALENT 1
MICRO-NX CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
NAKANISHI INC.
  SUBSTANTIALLY EQUIVALENT 2
NAKANISHI, INC.
  SUBSTANTIALLY EQUIVALENT 1
SAESHIN PRECISION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
W&H DENTALWERK BUERMOOS GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 13 13
2018 46 46
2019 55 55
2020 71 71
2021 57 57
2022 27 27

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 92 92
Detachment of Device or Device Component 84 84
Retraction Problem 32 32
Device Operates Differently Than Expected 16 16
Output Problem 14 14
Break 12 12
Device Damaged by Another Device 11 11
Therapeutic or Diagnostic Output Failure 11 11
Defective Device 7 7
Device Displays Incorrect Message 6 6
Loose or Intermittent Connection 6 6
Unintended Movement 6 6
Overheating of Device 5 5
Device Stops Intermittently 5 5
Calibration Problem 5 5
Loss of Power 4 4
Self-Activation or Keying 4 4
Incorrect Measurement 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Unexpected Shutdown 3 3
Inappropriate/Inadequate Shock/Stimulation 3 3
Device Slipped 2 2
Battery Problem 2 2
Device Inoperable 2 2
Use of Device Problem 2 2
Inappropriate or Unexpected Reset 2 2
Energy Output Problem 2 2
Material Separation 2 2
Product Quality Problem 2 2
Power Conditioning Problem 2 2
Protective Measures Problem 2 2
Appropriate Term/Code Not Available 2 2
Physical Resistance/Sticking 2 2
Mechanical Jam 2 2
Mechanics Altered 2 2
Bent 1 1
Insufficient Information 1 1
Positioning Problem 1 1
Power Problem 1 1
Unintended Electrical Shock 1 1
Data Problem 1 1
Intermittent Energy Output 1 1
Failure to Power Up 1 1
Device Remains Activated 1 1
Failure to Charge 1 1
Use of Incorrect Control/Treatment Settings 1 1
Positioning Failure 1 1
Display or Visual Feedback Problem 1 1
Electrical /Electronic Property Problem 1 1
Fluid/Blood Leak 1 1
Material Twisted/Bent 1 1
Failure to Auto Stop 1 1
Human Factors Issue 1 1
Computer Operating System Problem 1 1
Device Operational Issue 1 1
Defective Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 112 112
No Consequences Or Impact To Patient 102 102
No Known Impact Or Consequence To Patient 42 42
No Information 27 27
Insufficient Information 21 21
Device Embedded In Tissue or Plaque 7 7
No Code Available 4 4
Electric Shock 4 4
Foreign Body In Patient 2 2
Patient Problem/Medical Problem 1 1
Injury 1 1
Burn, Thermal 1 1
Hemorrhage/Bleeding 1 1
Pain 1 1
Perforation 1 1
Shock 1 1
Tactile Disorders 1 1
Paresthesia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 W & H DentalWerk Burmoos GMBH - Site 1 II Apr-11-2018
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