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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device dental amalgam
Definition Dental amalgam is a device that consists of a metallic alloy, such as silver, tin, copper, and zinc, that is mixed with liquid elemental mercury for the direct filling of carious lesions or structural defects in teeth
Product CodeOIV
Regulation Number 872.3070
Device Class 2


Premarket Reviews
ManufacturerDecision
WORLDWORK S.R.L
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 1 1
2021 4 4
2022 3 3
2023 8 8
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 7 7
Adverse Event Without Identified Device or Use Problem 2 2
Gas/Air Leak 1 1
Environmental Compatibility Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 4 4
Hypersensitivity/Allergic reaction 4 4
Fatigue 3 3
Anxiety 3 3
Malaise 3 3
Cognitive Changes 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Shaking/Tremors 2 2
Tics/Tremor 2 2
Unspecified Eye / Vision Problem 2 2
Speech Disorder 2 2
Weight Changes 2 2
Depression 2 2
Toxicity 2 2
Emotional Changes 2 2
Dysphasia 2 2
Inflammation 2 2
Twitching 2 2
Chills 1 1
Dizziness 1 1
Failure of Implant 1 1
Thyroid Problems 1 1
Tinnitus 1 1
Urinary Tract Infection 1 1
Vomiting 1 1
Immunodeficiency 1 1
Itching Sensation 1 1
Myocardial Infarction 1 1
Nausea 1 1
Hair Loss 1 1
Headache 1 1
Chest Pain 1 1
Death 1 1
Fungal Infection 1 1
Irritability 1 1
Deformity/ Disfigurement 1 1
Tissue Breakdown 1 1
Foreign Body In Patient 1 1
Patient Problem/Medical Problem 1 1
No Code Available 1 1
Multiple Organ Failure 1 1
Convulsion/Seizure 1 1
Taste Disorder 1 1
Confusion/ Disorientation 1 1
Unspecified Gastrointestinal Problem 1 1
Eczema 1 1
Unspecified Tissue Injury 1 1
Swelling/ Edema 1 1
Suicidal Ideation 1 1
Swollen Lymph Nodes/Glands 1 1

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