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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device oral wound dressing
Definition Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. Unclassified status per SE to MGQ.
Product CodeOLR
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
3-D MATRIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
FORWARD SCIENCE LLC
  SUBSTANTIALLY EQUIVALENT 1
MAXIGEN BIOTECH INC.
  SUBSTANTIALLY EQUIVALENT 1
PCCA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SA3, LLC
  SUBSTANTIALLY EQUIVALENT 1
SYNEDGEN, INC.
  SUBSTANTIALLY EQUIVALENT 1
TBM CORPORATION
  SUBSTANTIALLY EQUIVALENT 2

Recalls
Manufacturer Recall Class Date Posted
1 SA3, LLC II Apr-04-2022
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