Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum)

Rennou™ Varnish is a fluoride-free cavity varnish for professional topical application on prepared tooth surfaces to relieve tooth hypersensitivity by occluding open dentinal tubules. It is supplied as a unit-dose varnish and applicator in sealed trays and forms a rosin-based protective film on the tooth surface.

Like its predicate, Rennou™ Varnish provides prolonged contact of ingredients with the tooth surface, forms a protective barrier, and releases minerals to enhance tooth structure. The key technological difference is its formulation: it incorporates theobromine and calcium phosphate salts rather than sodium fluoride for occlusion benefits, similar to other cleared predicate devices containing novel mineral-deposition ingredients.

ISO 10993-5 (cytotoxicity biocompatibility testing) and USP <87> (biocompatibility assessment). Enamel protection and dentinal hypersensitivity testing included SEM analysis to confirm tubule occlusion and surface finish.

Rennou™ Varnish is substantially equivalent because it shares the same indications for use (relief of tooth hypersensitivity via mechanical dentinal tubule occlusion), the same product design (cavity varnish format), and the same technological characteristics (prolonged contact, protective barrier formation, mineral release) as the predicate Colgate® Prevident Varnish. Although the formulation differs—using theobromine and calcium phosphate instead of sodium fluoride—published literature demonstrates these novel ingredients facilitate mineral deposition and tubule occlusion, matching the mechanism of other cleared predicates like arginine-containing or bioglass-containing products. Biocompatibility testing shows acceptable safety comparable to or slightly better than the predicate, and no new safety or effectiveness questions arise from the composition change.