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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device teeth, porcelain
Product CodeELL
Regulation Number 872.3920
Device Class 2


Premarket Reviews
ManufacturerDecision
FRANZ BIOTECH INC.
  SUBSTANTIALLY EQUIVALENT 1
NOBEL BIOCARE AB
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 1 1
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Burst Container or Vessel 1 1
Leak/Splash 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Tooth Fracture 1 1
Chemical Exposure 1 1

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