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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device coating, filling material, resin
Regulation Description Coating material for resin fillings.
Product CodeEBD
Regulation Number 872.3310
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 3
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
KERR CORP.
  SUBSTANTIALLY EQUIVALENT 2

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