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510(k) Data Aggregation
K Number
K240619Device Name
e-SDF
Manufacturer
Kids-e-Dental LLP
Date Cleared
2024-03-06
(1 days)
Product Code
PHR
Regulation Number
872.3260Why did this record match?
Applicant Name (Manufacturer) :
Kids-e-Dental LLP
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
e-SDF is a single component liquid device made up of 38% silver diamine fluoride.Silver diamine fluoride solution is applied to the tooth, to reduce tooth sensitivity by physically occluding the open dentinal tubules. e-SDF is a liquid that is applied to the teeth using an applicator brush or similar application.
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