Search Results
Found 1 results
510(k) Data Aggregation
K Number
K113146Device Name
PCXX VARNISH
Manufacturer
Date Cleared
2012-01-23
(91 days)
Product Code
Regulation Number
872.3260Why did this record match?
Applicant Name (Manufacturer) :
ROSS HEALTHCARE INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
- Treatment of hypersensitive teeth
- Use on exposed dentin and root sensitivity
- Under temporary restoratives and cements where post-operative sensitivity is of concern.
Device Description
PCxx Varnish is 5% Sodium Fluoride Varnish that reduces tooth sensitivity by forming a film when topically applied to enamel and dentin surfaces. The properties, intended use and composition are equivalent to the predicated devices and other current varnishes which are rosin based insoluble mixtures that form a film when applied to tooth surfaces. PCxx Varnish used the same rosin (colophony) and rosin derivatives that are used in predicate devices which include but are not limited to Duraflor, Duraphat and Fluorilaq. The product comes in a single unit dose package containing the varnish and separate applicator brush.
Ask a Question
Ask a specific question about this device
Page 1 of 1