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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device instruments, dental hand
Regulation Description Dental hand instrument.
Product CodeDZN
Regulation Number 872.4565
Device Class 1

MDR Year MDR Reports MDR Events
2020 15 15
2021 21 21
2022 26 26
2023 38 38
2024 69 69
2025 31 31

Device Problems MDRs with this Device Problem Events in those MDRs
Break 173 173
Separation Failure 10 10
Material Deformation 6 6
Material Integrity Problem 2 2
Fracture 2 2
Component Incompatible 2 2
Patient-Device Incompatibility 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Patient Device Interaction Problem 1 1
Unraveled Material 1 1
Problem with Sterilization 1 1
Failure to Osseointegrate 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
Material Separation 1 1
Tear, Rip or Hole in Device Packaging 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 159 159
Insufficient Information 34 34
No Consequences Or Impact To Patient 6 6
No Known Impact Or Consequence To Patient 3 3
Failure of Implant 2 2
No Patient Involvement 2 2
Device Embedded In Tissue or Plaque 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Hypersensitivity/Allergic reaction 1 1
Intraoperative Pain 1 1
Tooth Fracture 1 1
Foreign Body In Patient 1 1
Erythema 1 1

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