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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device mouthpiece, saliva ejector
Regulation Description Dental operative unit and accessories.
Product CodeDYN
Regulation Number 872.6640
Device Class 1

MDR Year MDR Reports MDR Events
2020 8 8
2021 3 3
2022 1 1
2023 4 4
2024 1 1
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 13 13
Break 4 4
Mechanical Problem 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6 6
Foreign Body In Patient 4 4
No Consequences Or Impact To Patient 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Known Impact Or Consequence To Patient 1 1
Rash 1 1
Insufficient Information 1 1
Airway Obstruction 1 1

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