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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device unit, operative dental
Product CodeEIA
Regulation Number 872.6640
Device Class 1


Premarket Reviews
ManufacturerDecision
A-DEC, INC.
  SUBSTANTIALLY EQUIVALENT 1
AIOBIO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FOSHAN SAFETY MEDICAL EQUIPMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
LARES RESEARCH
  SUBSTANTIALLY EQUIVALENT 1
MEGAGEN IMPLANT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
MGNEWTON LTD.
  SUBSTANTIALLY EQUIVALENT 1
OLSEN INDUSTRIA E COMERCIO S.A.
  SUBSTANTIALLY EQUIVALENT 1
OLSEN INDÚSTRIA E COMÉRCIO S.A.
  SUBSTANTIALLY EQUIVALENT 1
OSSTEM IMPLANT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHINHUNG COMPANY LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 68 196
2020 48 131
2021 48 121
2022 44 131
2023 53 135
2024 9 37

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 102 407
Detachment of Device or Device Component 61 162
Unintended Power Up 26 33
Device Remains Activated 23 31
Fracture 20 57
Fluid/Blood Leak 14 28
Material Disintegration 6 12
Break 5 7
Unintended Ejection 3 4
Defective Device 3 3
Smoking 2 2
Vibration 1 1
Retraction Problem 1 1
Failure to Power Up 1 1
Corroded 1 6
Device Alarm System 1 1
Material Fragmentation 1 1
Fail-Safe Problem 1 1
Inappropriate or Unexpected Reset 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Mechanical Jam 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Insufficient Information 1 1
Ejection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 183 543
No Patient Involvement 69 173
Burn(s) 32 144
No Consequences Or Impact To Patient 17 93
No Known Impact Or Consequence To Patient 12 38
Insufficient Information 12 61
Burn, Thermal 3 33
Superficial (First Degree) Burn 2 2
Partial thickness (Second Degree) Burn 2 2
Full thickness (Third Degree) Burn 2 2
No Information 2 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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