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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
BELPORT COMPANY, INC., GINGI-PAK
  SUBSTANTIALLY EQUIVALENT 1
BREDENT GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
ID KOREA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VITA ZAHNFABRIK GMBH H RAUTER & CO
  SUBSTANTIALLY EQUIVALENT 1
YAMAHACHI DENTAL MFG., CO.
  SUBSTANTIALLY EQUIVALENT 1

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