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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
Defective Device 7 7
Device Displays Incorrect Message 7 7
Overheating of Device 7 7
Loose or Intermittent Connection 6 6
Incorrect Measurement 6 6
Unintended Movement 6 6
Device Stops Intermittently 5 5
Calibration Problem 5 5
Self-Activation or Keying 4 4
Material Separation 4 4
Loss of Power 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Unexpected Shutdown 3 3
Mechanics Altered 3 3
Inappropriate/Inadequate Shock/Stimulation 3 3
Device Inoperable 3 3
Use of Device Problem 2 2
Power Conditioning Problem 2 2
Defective Component 2 2
Battery Problem 2 2
Device Slipped 2 2
Failure to Power Up 2 2
Product Quality Problem 2 2
Energy Output Problem 2 2
Mechanical Jam 2 2
Inappropriate or Unexpected Reset 2 2
Failure to Shut Off 2 2
Protective Measures Problem 2 2
Temperature Problem 2 2
Appropriate Term/Code Not Available 2 2
Data Problem 2 2
Physical Resistance/Sticking 2 2
Intermittent Energy Output 2 2
Insufficient Information 1 1
Unintended Electrical Shock 1 1
Positioning Problem 1 1
Power Problem 1 1
Human Factors Issue 1 1
Failure to Auto Stop 1 1
Material Twisted/Bent 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
Device Remains Activated 1 1
Device Or Device Fragments Location Unknown 1 1
Computer Operating System Problem 1 1
Delivery System Failure 1 1
Device Operational Issue 1 1
Bent 1 1
Vibration 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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