510(k) No. K243777 confirms safety and efficacy of patented cacao-derived Rennou technology as an alternative to conventional fluoride varnishes
-- Theodent®, the science-driven oral-care company behind patented Rennou® technology, today announced the U.S. Food & Drug Administration has granted 510(k) clearance (K243777) for Rennou® Varnish, making it the first fluoride-free dental varnish authorized for professional use in the United States.
The Class II clearance under 21 CFR 872.3260 (product code LBH) affirms that Rennou® Varnish is substantially equivalent to existing fluoride varnishes in safety and effectiveness while leveraging proprietary cacao-derived Rennou® technology instead of fluoride.
“FDA clearance for Rennou® Varnish marks a pivotal advance in dentistry, giving clinicians a proven fluoride-free alternative to high-dose fluoride varnishes,” said Joseph Fuselier, Co-CEO of Theodent®. “The varnish is only the beginning. Our award-winning Theodent® toothpaste already delivers Rennou® at home, and now we’re expanding into a full professional line so every product—from chairside to bathroom sink—can strengthen smiles without fluoride.”
“Our team demonstrated that Rennou® occludes dentinal tubules, delivering the same clinical benefits practitioners expect from cavity varnish, but without the high doses of fluoride,” added Tetsuo Nakamoto, Ph.D., D.D.S., Co-CEO and Chief Scientific Officer.
“While I will likely keep some traditional 5% fluoride varnish on hand for those who request it, I intend to use Theodent’s Rennou® Varnish as my primary post-prophylaxis treatment once it’s released,” said Kristi Soileau, DDS, MEd, MSHCE. “Although many dentists still support public fluoridation, patients locally and nationally remain concerned about cumulative fluoride exposure. The FDA’s confirmation of Rennou’s efficacy and safety gives me a strong reason to switch.”
“For dentists seeking safe and effective alternatives to fluoride, the search is over. Patient interest in non-fluoride options is rising, driven by recent data on dose-related neurotoxicity,” said Margaret Scarlett, D.M.D., Former National Fluoridation Lead Officer, CDC, and Former Senior Policy Analyst, U.S. Department of Health & Human Services. “This new Rennou® varnish is a safe, highly effective solution applied just like a traditional varnish, allowing dentists to confidently provide a safer option for families concerned about their children’s total fluoride burden.”
Key Highlights
- FDA 510(k) Cleared (K243777): Regulatory validation as a Class II cavity varnish for dentinal hypersensitivity
- Fluoride-Free Formula: Patented Rennou® technology combines theobromine, calcium, and phosphate
- Familiar Workflow: 3 % resin matrix, rapid set time, and unit-dose packaging mirror standard varnish application
- Prescription-Only: Ensures professional application and oversight
- Patient-Friendly Flavors: Spearmint, Strawberry, Cherry, Bubble Gum
- Made in the USA: Manufactured in an FDA-registered, ISO-13485 facility
Availability
Rennou® Varnish will launch to U.S. dental professionals in Q4 2025. Theodent® is finalizing distribution partnerships, with further details forthcoming. International launches will follow pending local regulatory approvals.
For more information regarding Rennou® Varnish, please visit www.theodentpro.com.
About Theodent®
Founded in New Orleans, Theodent® (a subsidiary of Theocorp Holding Company) leverages proprietary Rennou® technology to create safe, effective oral-care products without fluoride. The company’s portfolio includes award-winning fluoride-free toothpastes, professional-strength formulations, and now the first FDA-cleared fluoride-free dental varnish. Learn more at www.theodent.com.
Contact Info:
Name: Communications Manager
Email: Send Email
Organization: Theodent®
Phone: +1 504-264-5050
Website: http://www.theodent.com
Release ID: 89162690
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