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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device zinc oxide eugenol
Regulation Description Dental cement.
Product CodeEMB
Regulation Number 872.3275
Device Class 1

MDR Year MDR Reports MDR Events
2021 1 1
2022 2 2
2023 1 1
2024 3 3
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2 2
Crack 2 2
Device Markings/Labelling Problem 2 2
Use of Device Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Patient-Device Incompatibility 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Contamination 1 1
Patient Device Interaction Problem 1 1
Delivered as Unsterile Product 1 1
Product Quality Problem 1 1
Protective Measures Problem 1 1
Appropriate Term/Code Not Available 1 1
Loss of or Failure to Bond 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Tooth Fracture 4 4
Dizziness 2 2
Foreign Body Reaction 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Extreme Exhaustion 1 1
Unspecified Infection 1 1
Neuropathy 1 1
Hypersensitivity/Allergic reaction 1 1
Necrosis 1 1
Transient Ischemic Attack 1 1
Vomiting 1 1
Depression 1 1
Suicidal Ideation 1 1
Dyspnea 1 1
Pain 1 1
Shaking/Tremors 1 1
Swelling/ Edema 1 1
Headache 1 1
Loss of Vision 1 1
Granuloma 1 1

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