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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device teeth, porcelain
Regulation Description Porcelain tooth.
Product CodeELL
Regulation Number 872.3920
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 2
LIFECORE BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
NOBEL BIOCARE
  SUBSTANTIALLY EQUIVALENT 5

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