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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device reamer, pulp canal, endodontic
Product CodeEKP
Regulation Number 872.4565
Device Class 1

MDR Year MDR Reports MDR Events
2016 4 4
2017 5 5
2018 1 1
2019 1 1
2020 5 5
2022 1 1
2023 3 3
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Break 24 24
Packaging Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Device Embedded In Tissue or Plaque 10 10
No Consequences Or Impact To Patient 9 9
No Clinical Signs, Symptoms or Conditions 4 4
No Information 4 4
No Known Impact Or Consequence To Patient 3 3
Injury 1 1
Insufficient Information 1 1

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