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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
OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS
  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 43 135

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 112 458
Detachment of Device or Device Component 67 183
Unintended Power Up 29 37
Device Remains Activated 26 34
Fracture 25 67
Fluid/Blood Leak 16 30
Material Disintegration 8 14
Break 5 7
Unintended Ejection 5 8
Defective Device 3 3
Material Fragmentation 2 2
Smoking 2 2
Corroded 1 6
Manufacturing, Packaging or Shipping Problem 1 1
Failure to Power Up 1 1
Ejection Problem 1 1
Vibration 1 1
Fail-Safe Problem 1 1
Mechanical Jam 1 1
Retraction Problem 1 1
Inappropriate or Unexpected Reset 1 1
Insufficient Information 1 1
Device Alarm System 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 215 639
No Patient Involvement 69 173
Burn(s) 38 204
Insufficient Information 19 111
No Consequences Or Impact To Patient 17 93
No Known Impact Or Consequence To Patient 12 38
Full thickness (Third Degree) Burn 3 3
Burn, Thermal 3 33
No Information 2 8
Partial thickness (Second Degree) Burn 2 2
Superficial (First Degree) Burn 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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