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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device dental amalgam
Regulation Description Dental amalgam, mercury, and amalgam alloy.
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
2021 4 17
2022 3 11
2023 8 8
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 6 27
Adverse Event Without Identified Device or Use Problem 2 2
Environmental Compatibility Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypersensitivity/Allergic reaction 4 12
Pain 3 20
Malaise 3 7
Cognitive Changes 3 16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Tics/Tremor 2 2
Speech Disorder 2 2
Unspecified Eye / Vision Problem 2 2
Depression 2 6
Shaking/Tremors 2 2
Weight Changes 2 2
Dysphasia 2 2
Anxiety 2 6
Inflammation 2 2
Twitching 2 2
Emotional Changes 2 6
Fatigue 2 15
Headache 1 1
Failure of Implant 1 1
Tinnitus 1 1
Urinary Tract Infection 1 1
Vomiting 1 1
Immunodeficiency 1 1
Chills 1 1
Dizziness 1 1
Itching Sensation 1 1
Nausea 1 1
Deformity/ Disfigurement 1 1
Tissue Breakdown 1 1
Foreign Body In Patient 1 1
Convulsion/Seizure 1 1
Chest Pain 1 1
Fungal Infection 1 1
Irritability 1 1
Unspecified Gastrointestinal Problem 1 1
Eczema 1 1
Unspecified Tissue Injury 1 1
Swelling/ Edema 1 1
Taste Disorder 1 5
Confusion/ Disorientation 1 5
Suicidal Ideation 1 1
Swollen Lymph Nodes/Glands 1 1

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