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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
A-DEC, INC.
  SUBSTANTIALLY EQUIVALENT 1
ANTHOGYR SAS
  SUBSTANTIALLY EQUIVALENT 1
BIEN-AIR DENTAL, SA
  SUBSTANTIALLY EQUIVALENT 1
BONART CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
CEFLA S.C.
  SUBSTANTIALLY EQUIVALENT 2
CODENT TECHNICAL INDUSTRY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DENTALEZ GROUP, STARDENTAL DIVISION
  SUBSTANTIALLY EQUIVALENT 1
DENTIUM CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY INTERNATIONAL INC.
  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
INNOVATIVE MEDICAL MANUFACTURING CO.
  SUBSTANTIALLY EQUIVALENT 1
KALTENBACH & VOIGT GMBH
  SUBSTANTIALLY EQUIVALENT 2
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 2
SAEYANG MICROTECH CO LTD
  SUBSTANTIALLY EQUIVALENT 1
SAEYANG MICROTECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SATELEC-ACTEON GROUP
  SUBSTANTIALLY EQUIVALENT 1
SCICAN LTD.
  SUBSTANTIALLY EQUIVALENT 1
TTBIO CORP.
  SUBSTANTIALLY EQUIVALENT 1
W&H DENTALWERK BUERMOOS GMBH
  SUBSTANTIALLY EQUIVALENT 1
W&H DENTALWERK BURMOOS GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 4 4
2015 13 13
2016 6 6
2017 13 13
2018 46 46
2019 55 55
2020 71 71
2021 57 57
2022 31 31
2023 17 17
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 116 116
Detachment of Device or Device Component 86 86
Retraction Problem 37 37
Device Operates Differently Than Expected 25 25
Break 16 16
Output Problem 15 15
Device Damaged by Another Device 13 13
Therapeutic or Diagnostic Output Failure 11 11
Device Displays Incorrect Message 7 7
Defective Device 7 7
Overheating of Device 7 7
Loose or Intermittent Connection 6 6
Unintended Movement 6 6
Incorrect Measurement 6 6
Device Stops Intermittently 5 5
Calibration Problem 5 5
Loss of Power 4 4
Material Separation 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Self-Activation or Keying 4 4
Device Inoperable 3 3
Inappropriate/Inadequate Shock/Stimulation 3 3
Unexpected Shutdown 3 3
Mechanics Altered 3 3
Failure to Shut Off 2 2
Device Slipped 2 2
Temperature Problem 2 2
Mechanical Jam 2 2
Protective Measures Problem 2 2
Failure to Power Up 2 2
Physical Resistance/Sticking 2 2
Battery Problem 2 2
Energy Output Problem 2 2
Power Conditioning Problem 2 2
Data Problem 2 2
Product Quality Problem 2 2
Defective Component 2 2
Inappropriate or Unexpected Reset 2 2
Use of Device Problem 2 2
Appropriate Term/Code Not Available 2 2
Intermittent Energy Output 2 2
Failure to Charge 1 1
Failure to Auto Stop 1 1
Electrical /Electronic Property Problem 1 1
Device Remains Activated 1 1
Power Problem 1 1
Vibration 1 1
Unintended Electrical Shock 1 1
Bent 1 1
Device Operational Issue 1 1
Material Twisted/Bent 1 1
Human Factors Issue 1 1
Positioning Failure 1 1
Use of Incorrect Control/Treatment Settings 1 1
Computer Operating System Problem 1 1
Fluid/Blood Leak 1 1
Insufficient Information 1 1
Display or Visual Feedback Problem 1 1
Device Or Device Fragments Location Unknown 1 1
Delivery System Failure 1 1
Positioning Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 133 133
No Consequences Or Impact To Patient 117 117
No Known Impact Or Consequence To Patient 47 47
No Information 28 28
Insufficient Information 28 28
Device Embedded In Tissue or Plaque 8 8
No Code Available 5 5
Electric Shock 4 4
Foreign Body In Patient 2 2
Full thickness (Third Degree) Burn 2 2
Patient Problem/Medical Problem 1 1
Tactile Disorders 1 1
Paresthesia 1 1
Injury 1 1
Sedation 1 1
Burn, Thermal 1 1
Burn(s) 1 1
Hemorrhage/Bleeding 1 1
Pain 1 1
Perforation 1 1
Shock 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Nobel Biocare Usa Llc II Nov-13-2013
2 W & H DentalWerk Burmoos GMBH - Site 1 II Apr-11-2018
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