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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device barrier, animal source, intraoral
Definition An animal source dental barrier is an animal-derived material device, such as collagen, intended to aid in guided tissue/bone regeneration procedures and to act as a stable barrier for the containment of bone graft materials when placed around implants.
Product CodeNPL
Regulation Number 872.3930
Device Class 2


Premarket Reviews
ManufacturerDecision
AROA BIOSURGERY LTD.
  SUBSTANTIALLY EQUIVALENT 1
BEIJING BIOSIS HEALING BIOLOGICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DATUM DENTAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
GEISTLICH PHARMA AG
  SUBSTANTIALLY EQUIVALENT 3
KERECIS
  SUBSTANTIALLY EQUIVALENT 1
KERECIS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
ORTHOCELL LTD
  SUBSTANTIALLY EQUIVALENT 1
PURGO BIOLOGICS INC.
  SUBSTANTIALLY EQUIVALENT 1
SIGMAGRAFT INC.
  SUBSTANTIALLY EQUIVALENT 1
SK BIOLAND CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 22 22
2020 8 8
2021 11 11
2022 19 19
2023 5 5
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 30 30
Adverse Event Without Identified Device or Use Problem 26 26
Appropriate Term/Code Not Available 5 5
Material Integrity Problem 3 3
Failure to Osseointegrate 3 3
Use of Device Problem 2 2
Osseointegration Problem 2 2
Material Split, Cut or Torn 2 2
Patient Device Interaction Problem 1 1
Biocompatibility 1 1
Degraded 1 1
Material Discolored 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Wound Dehiscence 26 26
Failure of Implant 24 24
Unspecified Infection 18 18
Inflammation 10 10
Pain 6 6
Insufficient Information 5 5
Implant Pain 3 3
No Code Available 3 3
Impaired Healing 3 3
No Known Impact Or Consequence To Patient 3 3
Inadequate Osseointegration 2 2
Abscess 2 2
Swelling/ Edema 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Hypersensitivity/Allergic reaction 2 2
Neuralgia 1 1
Malunion of Bone 1 1
Drug Resistant Bacterial Infection 1 1
Purulent Discharge 1 1
Headache 1 1
Laceration(s) 1 1
Nerve Damage 1 1
Tissue Breakdown 1 1
No Information 1 1
Post Operative Wound Infection 1 1
Osteolysis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Collagen Matrix Inc II Jan-29-2020
2 Collagen Matrix, Inc. II May-22-2019
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