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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device gutta-percha
Product CodeEKM
Regulation Number 872.3850
Device Class 1

MDR Year MDR Reports MDR Events
2018 3 3
2021 1 1
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 2 2
Unintended Electrical Shock 2 2
Inappropriate/Inadequate Shock/Stimulation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Electric Shock 2 2
No Information 1 1
Insufficient Information 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Hypersensitivity/Allergic reaction 1 1
Rash 1 1
No Consequences Or Impact To Patient 1 1

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