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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device syringe, periodontic, endodontic, irrigating
Regulation Description Dental hand instrument.
Product CodeEIC
Regulation Number 872.4565
Device Class 1

MDR Year MDR Reports MDR Events
2021 76 76
2022 11 11
2023 19 19
2024 22 22
2025 37 37
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 159 159
Insufficient Information 5 5
Inadequacy of Device Shape and/or Size 3 3
Entrapment of Device 2 2
Material Fragmentation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 118 118
Insufficient Information 75 75
Device Embedded In Tissue or Plaque 18 18
Foreign Body In Patient 5 5
Unspecified Tissue Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Stradis Medical, LLC dba Stradis Healthcare II Dec-14-2022
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