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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
Regulation Description Bone grafting material.
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 BIOLOG ICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BOTISS BIOMATERIALS GMBH
  SUBSTANTIALLY EQUIVALENT 1
COLLAGEN MATRIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
DATUM DENTAL, LTD.
  SUBSTANTIALLY EQUIVALENT 1
GEISTLICH PHARMA AG
  SUBSTANTIALLY EQUIVALENT 5
KERECIS
  SUBSTANTIALLY EQUIVALENT 1
NEO MODULUS (SUZHOU) MEDICAL SCI-TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOCELL, LTD.
  SUBSTANTIALLY EQUIVALENT 1
PURGO BIOLOGICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIGMAGRAFT, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 11 11
2022 19 19
2023 5 5
2024 20 20
2025 39 39
2026 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Device Problem Information 74 74
Adverse Event Without Identified Device or Use Problem 19 19
Osseointegration Problem 5 5
Material Integrity Problem 3 3
Use of Device Problem 1 1
Material Disintegration 1 1
Material Discolored 1 1
No Apparent Adverse Event 1 1
Patient Device Interaction Problem 1 1
Biocompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 29 29
Inflammation 26 26
Wound Dehiscence 24 24
Unspecified Infection 22 22
Insufficient Information 18 18
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 8 8
Pain 7 7
Hypersensitivity/Allergic reaction 6 6
Swelling/ Edema 5 5
Implant Pain 4 4
Abscess 3 3
Impaired Healing 3 3
Graft failure 3 3
No Clinical Signs, Symptoms or Conditions 2 2
Post Operative Wound Infection 2 2
Osteolysis 1 1
Foreign Body Reaction 1 1
Hepatitis 1 1
Inadequate Osseointegration 1 1
Necrosis 1 1
Malunion of Bone 1 1
Discomfort 1 1
Drug Resistant Bacterial Infection 1 1
Neuralgia 1 1
Perforation 1 1
Transmissible Spongiform Encephalopathy(TSE) 1 1
Itching Sensation 1 1
Hematoma 1 1
Numbness 1 1
Purulent Discharge 1 1
Physical Asymmetry 1 1
Headache 1 1

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