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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
MEDIZIN PRODUKTE NEUSTADT GMBH (MPN)
  SUBSTANTIALLY EQUIVALENT 1
MOLECULEX CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PCCA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SA3, LLC
  SUBSTANTIALLY EQUIVALENT 1
TBM CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ZINKH NV
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2025 5 5
2026 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Output Problem 1 1
No Apparent Adverse Event 1 1
Protective Measures Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 5 5
Dehydration 2 2
Hypersensitivity/Allergic reaction 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Burning Sensation 1 1
Diarrhea 1 1
Pain 1 1
Glossitis 1 1

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