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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
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
B&MEDI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
COWELLMEDI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CRITERIA INDUSTRIA E COMERCIO DE PRODUTOS MEDICINAIS
  SUBSTANTIALLY EQUIVALENT 1
OSTEOGENICS BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PURGO BIOLOGICS INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1 1
2021 2 2
2022 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5 5
Insufficient Information 3 3
Patient Device Interaction Problem 1 1
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Wound Dehiscence 4 4
Erosion 2 2
Foreign Body Reaction 2 2
Unspecified Infection 2 2
Local Reaction 2 2
Impaired Healing 1 1
Post Operative Wound Infection 1 1
Abrasion 1 1

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