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FDA 510(k)

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

K-Number: K243777 · 2025-05-27

ApplicantTheodent, LLC
Decision Date2025-05-27
Product CodeLBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum) is the device name listed in this FDA 510(k) record. The listed applicant is Theodent, LLC. It received FDA 510(k) clearance on 2025-05-27 under 510(k) number K243777. The device is classified under product code LBH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum)?

Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum) is a medical device that received FDA 510(k) clearance on 2025-05-27. The listed applicant is Theodent, LLC. The 510(k) number is K243777.

When did Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum) receive FDA 510(k) clearance?

Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum) received FDA 510(k) clearance on 2025-05-27, under 510(k) number K243777.

Who is the listed applicant for Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum)?

The FDA 510(k) record lists Theodent, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum)?

The FDA product code for Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum) is LBH.

Related Devices (Code: LBH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.