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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device diammine silver fluoride dental hypersensitivity varnish
Definition Applied to tooth enamel to block dentinal tubules for the purpose of reducing tooth sensitivity.
Product CodePHR
Regulation Number 872.3260
Device Class 2


Premarket Reviews
ManufacturerDecision
CENTRIX INC
  SUBSTANTIALLY EQUIVALENT 1
ELEVATE ORAL CARE, LLC
  SUBSTANTIALLY EQUIVALENT 1
KIDS-E-DENTAL LLP
  SUBSTANTIALLY EQUIVALENT 1
TEDEQUIM SRL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2022 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Product Quality Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Sensitivity of Teeth 1 1
Neuralgia 1 1
Insufficient Information 1 1

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