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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bone grafting material, synthetic
Regulation Description Bone grafting material.
Definition A synthetic bone grafting material is synthetically-derived device, such as hydroxylapatite, intended to fill, augment, or reconstruct periodontal and or bony defects of the upper or lower jaw.
Product CodeLYC
Regulation Number 872.3930
Device Class 2


Premarket Reviews
ManufacturerDecision
DIMENSION INX CORP.
  SUBSTANTIALLY EQUIVALENT 1
GC AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
INSTITUT STRAUMANN AG
  SUBSTANTIALLY EQUIVALENT 1
OSTEOGENE TECH CORP
  SUBSTANTIALLY EQUIVALENT 1
REVISIOS BV
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN DAZHOU MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 5 5
2021 12 12
2022 6 6
2023 9 9
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 12 12
Insufficient Information 7 7
Patient-Device Incompatibility 4 4
Product Quality Problem 4 4
Failure to Osseointegrate 3 3
Device Emits Odor 3 3
Patient Device Interaction Problem 2 2
Device Markings/Labelling Problem 1 1
Contamination 1 1
Osseointegration Problem 1 1
Loss of or Failure to Bond 1 1
Loss of Osseointegration 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 12 12
Unspecified Infection 10 10
Inadequate Osseointegration 8 8
Inflammation 8 8
Foreign Body Reaction 4 4
Sensitivity of Teeth 4 4
Implant Pain 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Hypersensitivity/Allergic reaction 2 2
Failure of Implant 2 2
Non-union Bone Fracture 2 2
Swelling/ Edema 2 2
Wound Dehiscence 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Necrosis 1 1
Skin Inflammation/ Irritation 1 1
Burning Sensation 1 1
Foreign Body In Patient 1 1
Rash 1 1
Fever 1 1
Insufficient Information 1 1
No Consequences Or Impact To Patient 1 1

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