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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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
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.
  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
2022 44 131

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 134 580
Detachment of Device or Device Component 55 171
Device Remains Activated 38 61
Unintended Power Up 32 49
Disassembly 16 39
Fracture 15 39
Fluid/Blood Leak 13 29
Break 9 11
Leak/Splash 6 9
Material Disintegration 5 8
Smoking 5 5
Metal Shedding Debris 2 2
Defective Device 2 2
Device Displays Incorrect Message 2 24
Unintended Ejection 2 2
Material Fragmentation 2 4
No Device Output 1 1
Retraction Problem 1 1
Peeled/Delaminated 1 1
Detachment Of Device Component 1 1
Corroded 1 6
Device Alarm System 1 1
Defective Component 1 1
Cut In Material 1 1
Device Markings/Labelling Problem 1 16
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
Unintended Movement 1 1
Ejection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 147 406
No Clinical Signs, Symptoms or Conditions 123 373
No Known Impact Or Consequence To Patient 42 153
Burn(s) 33 136
No Consequences Or Impact To Patient 32 127
Burn, Thermal 7 73
Insufficient Information 5 18
No Information 4 12
Superficial (First Degree) Burn 4 45
Partial thickness (Second Degree) Burn 3 3
Full thickness (Third Degree) Burn 2 2
Foreign Body In Patient 1 1
Anaphylactic Shock 1 1
Reaction 1 1
Laceration(s) 1 1

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