← Back to catalogue

Activ Varnish

FDA 510(k)

Class II (US FDA 510(k))

510(k) K112946

by Pulpdent Corporation

Identifiers

510(k) Number
K112946 FDA 510(k)
FDA Product Code
LBH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3260 FDA 510(k)
Regulation Number
872.3260 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Activ Varnish is a resin-based dental varnish designed for professional application to enamel or dentin. It contains 17% xylitol and less than 20% ethanol, serving as a protective coating to address dental hypersensitivity.

This device is supplied as a single-use application in dental settings and is classified under FDA product code LBH (Cavity Varnish). It is regulated under 21 CFR 872.3260 and holds FDA 510(k) clearance (K112946) via the Traditional pathway. Sterility and packaging details are not specified in the provided data.

Frequently asked questions

What is the primary purpose of Activ Varnish in dental treatments?

Activ Varnish is a resin-based dental varnish designed to create a protective coating on enamel or dentin. It contains 17% xylitol and less than 20% ethanol, primarily to address dental hypersensitivity by shielding sensitive areas.

Is Activ Varnish intended for single-use or repeated applications?

Activ Varnish is supplied as a single-use application in dental settings, meaning each unit is intended for one professional application per patient.

How is Activ Varnish regulated and approved in the U.S.?

Activ Varnish holds FDA 510(k) clearance (K112946) through the Traditional pathway, meaning it was determined to be substantially equivalent to a legally marketed predicate device. It is classified under FDA product code LBH (Cavity Varnish) and regulated under 21 CFR 872.3260.

What are the key ingredients in Activ Varnish, and how do they contribute to its function?

Activ Varnish contains 17% xylitol, a sugar substitute known for its potential to reduce dental plaque and promote oral health, and less than 20% ethanol, which likely aids in the varnish’s application and drying process. Together, these ingredients form a protective resin coating to help manage dental hypersensitivity.

Are there any specific storage instructions or considerations for Activ Varnish?

The provided data does not specify storage instructions or conditions for Activ Varnish. Clinicians should refer to the manufacturer’s instructions or packaging for proper storage guidance to ensure product integrity.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K112946 - ACTIV VARNISH | FDA 510(k) | Pulpdent Corporation, PDF K112946 - Activ Varnish, ACTIV VARNISH (K112946) — FDA 510 (k) | Innolitics, PDF IYIL RibAct/v Varnish - Food and Drug Administration

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Pulpdent Corporation

Sources (1)

  • FDA 510(k) K112946 24 fields · synced Sep 18, 2026