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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device light, operating, dental
Regulation Description Dental operating light.
Product CodeEAZ
Regulation Number 872.4630
Device Class 1

MDR Year MDR Reports MDR Events
2020 3 3
2021 8 8
2023 2 2
2024 7 7
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Device Fell 18 18
Break 2 2
Device Handling Problem 2 2
Therapeutic or Diagnostic Output Failure 1 1
Detachment of Device or Device Component 1 1
Installation-Related Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11 11
Bruise/Contusion 4 4
Burning Sensation 2 2
No Known Impact Or Consequence To Patient 1 1
Neck Pain 1 1
Concussion 1 1
Insufficient Information 1 1
Laceration(s) 1 1
Pain 1 1

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