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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pick, massaging
Regulation Description Massaging pick or tip for oral hygiene.
Product CodeJET
Regulation Number 872.6650
Device Class 1

MDR Year MDR Reports MDR Events
2021 2 3
2022 39 39
2023 17 17
2024 12 12
2025 12 12
2026 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Break 69 70
Detachment of Device or Device Component 12 12
Material Separation 5 5
Material Fragmentation 2 2
Defective Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 52 52
Insufficient Information 20 20
Device Embedded In Tissue or Plaque 9 10
Foreign Body In Patient 2 2
Laceration(s) 2 2
Skin Inflammation/ Irritation 1 2
Upper Respiratory Tract Injury 1 1
Abscess 1 1
Choking 1 1
Discomfort 1 1
Inflammation 1 1
Pain 1 1
Tooth Fracture 1 1
Sore Throat 1 2

Recalls
Manufacturer Recall Class Date Posted
1 Young Dental Manufacturing I, LLC III Dec-19-2022
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