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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device handpiece, direct drive, ac-powered
Product CodeEKX
Regulation Number 872.4200
Device Class 1


Premarket Reviews
ManufacturerDecision
APEXUM LTD.
  SUBSTANTIALLY EQUIVALENT 1
ASEPTICO, INC.
  SUBSTANTIALLY EQUIVALENT 4
BY DENTAL SRL
  SUBSTANTIALLY EQUIVALENT 1
CHANGZHOU BOMEDENT MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DENTAMERICA
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY INTERNTIONAL
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 1
DISCUS DENTAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
DMS CO., LTD.
  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
HIOSSEN, INC.
  SUBSTANTIALLY EQUIVALENT 1
J. MORITA USA, INC.
  SUBSTANTIALLY EQUIVALENT 3
META BIOMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
META SYSTEMS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
META SYSTEMS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MICRO-NX CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
MICRO-NX CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NAKANISHI, INC.
  SUBSTANTIALLY EQUIVALENT 2
OSSTELL AB
  SUBSTANTIALLY EQUIVALENT 3
PERIMETRICS, INC
  SUBSTANTIALLY EQUIVALENT 1
PREMIER DENTAL COMPANY PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
SAESHIN PRECISION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
SAEYANG MICROTECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SAEYANG MICROTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN PERFECT MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TELLOS MEDICAL AB
  SUBSTANTIALLY EQUIVALENT 1
W & H DENTALWERK BUERMOOS GMBH
  SUBSTANTIALLY EQUIVALENT 2
W&H DENTALWERK BUERMOOS GMBH
  SUBSTANTIALLY EQUIVALENT 1
YOUNG DENTAL MANUFACTURING CO 1, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 102 102
2015 68 68
2016 66 66
2017 10 10
2018 49 49
2019 56 56
2020 67 67
2021 79 79
2022 37 37
2023 14 14
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 214 214
Detachment of Device or Device Component 148 148
Mechanical Problem 99 99
Retraction Problem 40 40
Device Operates Differently Than Expected 33 33
Defective Device 32 32
Unintended Movement 24 24
Self-Activation or Keying 23 23
Dent in Material 22 22
Therapeutic or Diagnostic Output Failure 18 18
Break 18 18
Computer Operating System Problem 17 17
Output Problem 15 15
Physical Resistance/Sticking 15 15
Device Handling Problem 11 11
Temperature Problem 10 10
Inappropriate/Inadequate Shock/Stimulation 9 9
Failure to Calibrate 8 8
Unintended Electrical Shock 7 7
Device Damaged by Another Device 5 5
Energy Output Problem 5 5
Material Separation 5 5
Loose or Intermittent Connection 5 5
Device Maintenance Issue 4 4
Failure To Service 4 4
Improper or Incorrect Procedure or Method 4 4
Mechanics Altered 4 4
Noise, Audible 3 3
Insufficient Information 3 3
Appropriate Term/Code Not Available 3 3
Device Slipped 3 3
Smoking 2 2
Device Inoperable 2 2
Use of Device Problem 2 2
Defective Component 2 2
Electrical /Electronic Property Problem 2 2
Fluid/Blood Leak 2 2
Leak/Splash 2 2
Data Problem 2 2
Positioning Problem 2 2
Protective Measures Problem 2 2
Device Fell 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Loss of Data 2 2
Failure to Align 2 2
Calibration Problem 2 2
Failure to Advance 1 1
Fail-Safe Problem 1 1
Failure to Auto Stop 1 1
Failure to Shut Off 1 1
Inappropriate or Unexpected Reset 1 1
Maintenance Does Not Comply To Manufacturers Recommendations 1 1
Mechanical Jam 1 1
No Audible Alarm 1 1
Loss of or Failure to Bond 1 1
Calibration Error 1 1
Detachment Of Device Component 1 1
Component Falling 1 1
Display or Visual Feedback Problem 1 1
Device Emits Odor 1 1
Device Issue 1 1
Fitting Problem 1 1
Device Displays Incorrect Message 1 1
Sparking 1 1
Patient-Device Incompatibility 1 1
No Device Output 1 1
Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 246 246
No Clinical Signs, Symptoms or Conditions 167 167
No Known Impact Or Consequence To Patient 92 92
Burn, Thermal 71 71
No Information 24 24
Insufficient Information 19 19
Burn(s) 19 19
Electric Shock 13 13
No Patient Involvement 3 3
Partial thickness (Second Degree) Burn 2 2
Device Embedded In Tissue or Plaque 2 2
Shock 2 2
Vomiting 1 1
Hemorrhage/Bleeding 1 1
Blood Loss 1 1
Reaction 1 1
Choking 1 1
Not Applicable 1 1
Inadequate Osseointegration 1 1
Superficial (First Degree) Burn 1 1
Foreign Body In Patient 1 1
Patient Problem/Medical Problem 1 1

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