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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
COLLAGEN MATRIX, INC.
  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
  1.  K230091  THE Cover
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 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 40 40
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
Material Split, Cut or Torn 2 2
Use of Device Problem 2 2
Osseointegration Problem 2 2
Patient Device Interaction Problem 1 1
Degraded 1 1
Material Discolored 1 1
Biocompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Wound Dehiscence 27 27
Failure of Implant 26 26
Unspecified Infection 19 19
Inflammation 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Pain 6 6
Insufficient Information 5 5
Impaired Healing 3 3
No Code Available 3 3
Implant Pain 3 3
No Known Impact Or Consequence To Patient 3 3
Hypersensitivity/Allergic reaction 2 2
Inadequate Osseointegration 2 2
Abscess 2 2
Swelling/ Edema 2 2
Drug Resistant Bacterial Infection 1 1
No Clinical Signs, Symptoms or Conditions 1 1
No Information 1 1
Hematoma 1 1
Perforation 1 1
Purulent Discharge 1 1
Post Operative Wound Infection 1 1
Hepatitis 1 1
Nerve Damage 1 1
Osteolysis 1 1
Numbness 1 1
Laceration(s) 1 1
Malunion of Bone 1 1
Headache 1 1
Tissue Breakdown 1 1
Neuralgia 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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