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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device handle, instrument, dental
Product CodeEJB
Regulation Number 872.4565
Device Class 1


Premarket Reviews
ManufacturerDecision
CENTRIX, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 2 2
2015 1 1
2016 1 1
2019 1 1
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment Of Device Component 2 2
Fracture 2 2
Device Inoperable 1 1
Defective Device 1 1
Detachment of Device or Device Component 1 1
Break 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 2 2
Burn, Thermal 1 1
No Known Impact Or Consequence To Patient 1 1
No Information 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Pain 1 1

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