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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device barrier, synthetic, intraoral
Regulation Description Bone grafting material.
Definition A synthetic dental barrier is a synthetic material device, such as ptfe, intended to aid in guided tissue and/or bone regeneration procedures and to act as a stable barrier for the containment of bone graft materials.
Product CodeNPK
Regulation Number 872.3930
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 2
ETHICON
  SUBSTANTIALLY EQUIVALENT 1
INION
  SUBSTANTIALLY EQUIVALENT 1
POREX SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
SAMYANG CORP.
  SUBSTANTIALLY EQUIVALENT 1
STRAUMANN
  SUBSTANTIALLY EQUIVALENT 1
W.L. GORE & ASSOCIATES,INC
  SUBSTANTIALLY EQUIVALENT 5

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