Rennou™ Varnish: The First FDA-Cleared, Fluoride-Free Cavity Varnish

Theodent is proud to introduce Rennou™ Varnish, a significant advancement in fluoride-free dental care. Our patented Rennou™ technology, developed through years of dedicated research, is now 510(k) cleared by the FDA for professional use.

As the world's first 510(k) cleared fluoride-free cavity varnish, Rennou™ offers effective desensitization and protection, meeting the needs of clinicians seeking alternatives to traditional fluoride products.

Available in four patient-friendly flavors: Spearmint, Strawberry, Cherry, and Bubble Gum.

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Rennou Varnish Products - All Flavors

Why Choose Rennou™ Varnish?

I

Safety

Rennou™ Varnish is formulated without fluoride. This addresses concerns related to fluoride ingestion, offering an alternative for all patients, including pediatric cases where accidental swallowing may be a consideration.

II

Efficacy

Rennou™ Varnish provides effective relief from dentinal hypersensitivity by mechanically occluding tubules, as per its 510(k) clearance. Supporting in vitro studies show its occlusive capabilities are comparable to 5% sodium fluoride varnish.

III

Patented Technology

Theodent's patented Rennou™ technology is at the heart of this unique varnish. It represents a novel, fluoride-free advancement in materials for professional dental care, specifically for its cleared indications.

Rennou Varnish - Spearmint
Rennou Varnish - Cherry
Rennou Varnish - Bubblegum
Rennou Varnish - Strawberry

How Rennou™ Varnish Works

Rennou™ Varnish is designed to offer a familiar clinical experience, with an application protocol, drying time, and protective barrier formation comparable to the fluoride varnishes you currently use. Being fluoride-free, it addresses potential concerns regarding fluoride ingestion, particularly in pediatric patients. Clinicians can seamlessly integrate Rennou™ Varnish into their practice using their existing techniques.

This fluoride-free dental varnish provides relief of dentinal hypersensitivity and protection of exposed dentin through mechanical occlusion of dentinal tubules. The fast-drying, rosin-based formula creates a protective barrier that shields the nerves within the dentin pulp.

Application Protocol

  1. Clean and dry the tooth surface
  2. Mix the varnish thoroughly before application
  3. Apply in a thin layer using the provided applicator
  4. Allow to dry, forming a protective barrier
  5. Varnish hardens on contact with saliva

Patients should avoid eating hard foods or brushing the treated area for 4-6 hours after application to allow for maximum benefit.

Product Composition

Active System:

Complete Ingredients:

  • Rosin
  • Ethanol
  • Xylitol
  • Theobromine
  • Calcium Acetate
  • Sodium Hydrogen Phosphate
  • Natural Flavoring

Performance Data Overview

A recent in vitro study published in the Journal of Clinical Pediatric Dentistry (2024) compared Rennou™ Varnish to traditional fluoride varnishes. The study found that both 1% and 3% Rennou™ formulations showed dentinal tubule occlusion comparable to 5% sodium fluoride varnish.

Key Finding: "All varnishes treated artificial enamel lesions to varying degrees. However, both concentrations of Rennou showed remineralization potential comparable to 5% NaF in acceptable statistical measurements."

Parlakyildiz Gokce, A.N., et al. (2024). "Remineralization potential of a novel varnish: an in vitro comparative evaluation." Journal of Clinical Pediatric Dentistry.

Professional Information

Indications: Relief of tooth hypersensitivity through mechanical occlusion of dentinal tubules.

Storage: Store at 2-27°C (36-80°F) in a cool, dry place.

Contraindications: Do not use on patients with known sensitivity to any ingredients, including rosin.

Professional Use Only: Single-use application by licensed dental professionals.

FDA 510(k) Clearance

On May 27, 2025, the FDA granted 510(k) clearance (K243777) for Rennou™ Varnish, marking a historic milestone in fluoride-free dental care.

View FDA Clearance Letter

Pricing and Ordering Coming Soon

We're finalizing distribution channels to bring Rennou™ Varnish to dental professionals. Rennou Varnish™ is expected to launch later this year.

For more information, please contact:
andrew@theo-corp.com

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