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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device heat source for bleaching teeth
Regulation Description Heat source for bleaching teeth.
Product CodeEEG
Regulation Number 872.6475
Device Class 1

MDR Year MDR Reports MDR Events
2021 6 6
2022 4 4
2024 1 1
2025 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Patient Device Interaction Problem 7 7
Adverse Event Without Identified Device or Use Problem 3 3
Unintended Electrical Shock 2 2
Patient-Device Incompatibility 2 2
Improper or Incorrect Procedure or Method 2 2
Smoking 1 1
Product Quality Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burning Sensation 8 8
Pain 8 8
Hypersensitivity/Allergic reaction 7 7
Swelling/ Edema 7 7
Peeling 6 6
Numbness 5 5
Increased Sensitivity 4 4
No Clinical Signs, Symptoms or Conditions 3 3
Tooth Fracture 2 2
Caustic/Chemical Burns 2 2
Dysphasia 1 1
Sleep Dysfunction 1 1
Arrhythmia 1 1
Electric Shock 1 1
Burn, Thermal 1 1
Blister 1 1
Burn(s) 1 1
Erythema 1 1
Discomfort 1 1
Unspecified Respiratory Problem 1 1
Headache 1 1
Deformity/ Disfigurement 1 1
Sensitivity of Teeth 1 1

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