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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device zinc oxide eugenol
Product CodeEMB
Regulation Number 872.3275
Device Class 1


Premarket Reviews
ManufacturerDecision
DENTIST IN A BOX PTY. LTD
  SUBSTANTIALLY EQUIVALENT 1
DMG USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
VOCO GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1 1
2022 2 2
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Improper or Incorrect Procedure or Method 2 2
Adverse Event Without Identified Device or Use Problem 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Dizziness 2 2
Tooth Fracture 1 1
Shaking/Tremors 1 1
Swelling/ Edema 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Dyspnea 1 1
Extreme Exhaustion 1 1
Headache 1 1
Hypersensitivity/Allergic reaction 1 1
Vomiting 1 1

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