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510(k) Data Aggregation
K Number
K243777Device 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
872.3260Why 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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