Search Results
Found 1 results
510(k) Data Aggregation
K Number
K240059Device Name
FAgamin®
Manufacturer
Tedequim SRL
Date Cleared
2024-05-16
(129 days)
Product Code
PHR
Regulation Number
872.3260Why did this record match?
Applicant Name (Manufacturer) :
Tedequim SRL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Treatment of dentinal hypersensitivity. For use in adults over the age of 21.
Device Description
FAgamin® is a professional treatment for dentin hypersensitivity. It is indicated for adults over 21 years of age.
FAgamin® is presented in a 5 ml black dropper bottle and contains a 38% w/v solution of diamine silver fluoride. Its design includes a secure screw cap and labeled container.
Ask a Question
Page 1 of 1