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510(k) Data Aggregation

    K Number
    K243777
    Device Name
    Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum)
    Manufacturer
    Theodent, LLC
    Date Cleared
    2025-05-27

    (169 days)

    Product Code
    LBH
    Regulation Number
    872.3260
    Why did this record match?
    Applicant Name (Manufacturer) :

    Theodent, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Rennou™ Varnish is indicated for the relief of tooth hypersensitivity through the mechanical occlusion of dentinal tubules.
    Device Description
    Rennou™ Varnish is a cavity varnish intended for professional use as a topical application on prepared tooth surfaces. This fluoride-free varnish creates a rosin-based film that prevents penetration of restorative material into the dentinal tissue and provides relief of tooth hypersensitivity by occluding open dentinal tubules. Unit-dose varnish and applicator are packaged together in individual thin, sealed trays. Rennou™ Varnish is only applied by a professional clinician. Rennou™ Varnish is a topically applied flavored (Spearmint, etc.) compound comprised of natural rosin, ethanol, xylitol, and Rennou™ (a combination of theobromine, calcium acetate, and sodium hydrogen phosphate). The major components are rosin and ethanol, which, when delivered together, efficiently promote a fast-drying film on the tooth surface. The varnish is sweetened with xylitol.
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