Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device diammine silver fluoride dental hypersensitivity varnish
Regulation Description Cavity 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
BELPORT COMPANY, INC., GINGI-PAK
  SUBSTANTIALLY EQUIVALENT 1
CENTRIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
ELEVATE ORAL CARE, LLC
  SUBSTANTIALLY EQUIVALENT 1
KIDS-E-DENTAL LLP
  SUBSTANTIALLY EQUIVALENT 1
TEDEQUIM SRL
  SUBSTANTIALLY EQUIVALENT 1
YOUNG DENTAL MANUFACTURING CO. 1, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2022 1 1
2023 1 1
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1 1
Product Quality Problem 1 1

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

-
-