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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device reliner, denture, over the counter
Regulation Description OTC denture reliner.
Product CodeEBP
Regulation Number 872.3560
Device Class 2

MDR Year MDR Reports MDR Events
2021 1 1
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Fitting Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Product Quality Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypersensitivity/Allergic reaction 1 1
Fatigue 1 1
Failure of Implant 1 1
Nausea 1 1
Diaphoresis 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Dizziness 1 1
Pain 1 1

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