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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device alloy, amalgam
Product CodeEJJ
Regulation Number 872.3070
Device Class 2

MDR Year MDR Reports MDR Events
2019 1 1
2020 1 1
2021 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Device Ingredient or Reagent Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Anxiety 3 3
Toxicity 2 2
Numbness 1 1
Diaphoresis 1 1
Shaking/Tremors 1 1
Confusion/ Disorientation 1 1
Chemical Exposure 1 1
Cancer 1 1
Speech Disorder 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Emotional Changes 1 1
Hair Loss 1 1
Headache 1 1
Pain 1 1
Thyroid Problems 1 1
Blurred Vision 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ivoclar Vivadent, Inc. II Feb-07-2024
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