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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device instrument, diamond, dental
Regulation Description Dental diamond instrument.
Product CodeDZP
Regulation Number 872.4535
Device Class 1

MDR Year MDR Reports MDR Events
2020 1 1
2021 6 6
2022 4 4
2023 5 5
2024 8 8
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 10 10
Material Twisted/Bent 8 8
Unintended Movement 4 4
Unintended Ejection 4 4
Device Damaged by Another Device 4 4
Vibration 2 2
Detachment of Device or Device Component 2 2
Device Dislodged or Dislocated 2 2
Entrapment of Device 1 1
Mechanical Problem 1 1
Insufficient Information 1 1
Material Integrity Problem 1 1
Material Fragmentation 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Tooth Fracture 7 7
Insufficient Information 6 6
No Clinical Signs, Symptoms or Conditions 5 5
Device Embedded In Tissue or Plaque 4 4
Laceration(s) 3 3
Foreign Body In Patient 2 2
Pain 2 2

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