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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Product CodeJET
Regulation Number 872.6650
Device Class 1

MDR Year MDR Reports MDR Events
2021 2 2
2022 39 39
2023 17 17
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Break 53 53
Material Separation 4 4
Detachment of Device or Device Component 4 4
Adverse Event Without Identified Device or Use Problem 2 2
Material Fragmentation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 28 28
Insufficient Information 20 20
Device Embedded In Tissue or Plaque 9 9
Laceration(s) 2 2
Foreign Body In Patient 2 2
Sore Throat 1 1
Tooth Fracture 1 1
Choking 1 1
Skin Inflammation/ Irritation 1 1
Abscess 1 1
Inflammation 1 1

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