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TPLC
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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 Code
LYC
Regulation Number
872.3930
Device Class
2
Premarket Reviews
Manufacturer
Decision
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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