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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
Regulation Description Dental operative unit and accessories.
Product CodeEIA
Regulation Number 872.6640
Device Class 1


Premarket Reviews
ManufacturerDecision
AIOBIO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FOREST DENTAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
OLSEN INDUSTRIA E COMERCIO S.A.
  SUBSTANTIALLY EQUIVALENT 1
OSSTEM IMPLANT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OSSTEM IMPLANT CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
PELTON & CRANE
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 64 222
2018 73 256
2019 68 196
2020 48 131
2021 48 121

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 119 510
Detachment of Device or Device Component 44 152
Device Remains Activated 36 59
Unintended Power Up 30 47
Disassembly 16 39
Fracture 10 26
Break 9 11
Fluid Leak 9 12
Leak/Splash 6 9
Smoking 4 4
Material Disintegration 3 3
Material Fragmentation 2 4
Metal Shedding Debris 2 2
Defective Device 2 2
Device Displays Incorrect Message 2 24
Defective Component 1 1
Cut In Material 1 1
Device Markings/Labelling Problem 1 16
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
Unintended Movement 1 1
Ejection Problem 1 1
No Device Output 1 1
Retraction Problem 1 1
Peeled/Delaminated 1 1
Unintended Ejection 1 1
Device Alarm System 1 1
Detachment Of Device Component 1 1
Corroded 1 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 147 406
No Clinical Signs, Symptoms or Conditions 80 243
No Known Impact Or Consequence To Patient 42 153
No Consequences Or Impact To Patient 32 127
Burn(s) 25 74
Burn, Thermal 7 73
Superficial (First Degree) Burn 4 45
No Information 4 12
Insufficient Information 4 15
Partial thickness (Second Degree) Burn 3 3
Full thickness (Third Degree) Burn 2 2
Foreign Body In Patient 1 1
Anaphylactic Shock 1 1
Laceration(s) 1 1
Reaction 1 1

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