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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device unit, electrosurgical, and accessories, dental
Product CodeEKZ
Regulation Number 872.4920
Device Class 2


Premarket Reviews
ManufacturerDecision
J. MORITA USA, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1 1
2018 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Application Program Problem: Dose Calculation Error 4 4
Programming Issue 1 1
Insufficient Information 1 1
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 4 4
Tissue Damage 1 1
Osteolysis 1 1
Burn, Thermal 1 1
No Information 1 1

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