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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
FOREST DENTAL PRODUCTS, INC.
  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
OSSTEM IMPLANT CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
PELTON & CRANE
  SUBSTANTIALLY EQUIVALENT 1
SHINHUNG COMPANY LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 64 222
2018 73 256
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 167 727
Detachment of Device or Device Component 74 221
Device Remains Activated 46 71
Unintended Power Up 41 60
Fracture 25 67
Fluid/Blood Leak 18 35
Disassembly 16 39
Break 9 11
Material Disintegration 8 14
Leak/Splash 6 9
Unintended Ejection 6 9
Smoking 5 5
Defective Device 3 3
Material Fragmentation 3 5
Adverse Event Without Identified Device or Use Problem 2 2
Metal Shedding Debris 2 2
Device Displays Incorrect Message 2 24
Cut In Material 1 1
Peeled/Delaminated 1 1
Device Alarm System 1 1
Device Markings/Labelling Problem 1 16
Unintended Movement 1 1
Insufficient Information 1 1
Defective Component 1 1
Vibration 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Ejection Problem 1 1
Fail-Safe Problem 1 1
Failure to Power Up 1 1
Retraction Problem 1 1
Inappropriate or Unexpected Reset 1 1
Mechanical Jam 1 1
Corroded 1 6
No Device Output 1 1
Detachment Of Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 215 639
No Patient Involvement 147 406
Burn(s) 45 235
No Known Impact Or Consequence To Patient 42 153
No Consequences Or Impact To Patient 32 127
Insufficient Information 19 111
Burn, Thermal 7 73
Superficial (First Degree) Burn 5 46
No Information 4 12
Partial thickness (Second Degree) Burn 3 3
Full thickness (Third Degree) Burn 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Foreign Body In Patient 1 1
Laceration(s) 1 1
Reaction 1 1
Anaphylactic Shock 1 1

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