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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device handpiece, belt and/or gear driven, dental
Regulation Description Dental handpiece and accessories.
Product CodeEFA
Regulation Number 872.4200
Device Class 1

MDR Year MDR Reports MDR Events
2022 4 4
2023 3 3
2024 5 5
2025 4 4
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 12 12
Use of Device Problem 5 5
Physical Resistance/Sticking 2 2
Dent in Material 1 1
Detachment of Device or Device Component 1 1
Excessive Heating 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burn(s) 11 11
Superficial (First Degree) Burn 3 3
No Clinical Signs, Symptoms or Conditions 2 2
Foreign Body In Patient 1 1

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