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Fluorilaq

FDA 510(k)

Class II (US FDA 510(k))

510(k) K030488

by Pascal Co., Inc.

Identifiers

510(k) Number
K030488 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)

Fluorilaq is a varnish, cavity device classified under dental specialty. It is a 5% sodium fluoride varnish with xylitol, premixed for precise droplet delivery, and dries clear after application.

Supplied in formats such as squeeze tubes and econotubes, Fluorilaq is intended for preventive dental use. It is a single-use device, non-sterile, and not indicated for MRI safety. Authorized via FDA 510(k) clearance (K030488), it is regulated as a Class II medical device under regulation number 872.3260.

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: Fluorilaq™ Squeeze Fluoride Varnish - Pascal, Fluorilaq Squeeze 10-420 Fluoride - Henry Schein Dental, Fluorilaq 5% Sodium Fluoride Varnish | 10mL EconoTube - Pascal, Fluorilaq Squeeze 10-425 Fluoride - Henry Schein Dental

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Pascal Co., Inc.

Sources (1)

  • FDA 510(k) K030488 24 fields · synced Sep 26, 2026