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Profluoro Fluoride Varnish

FDA 510(k)

Class II (US FDA 510(k))

510(k) K141422

by Pac-Dent International, Inc.

Identifiers

510(k) Number
K141422 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)

The Profluoro Fluoride Varnish is a dental varnish used for professional treatment of dental hypersensitivity by occluding dentinal tubules with an adherent film. It is classified as a cavity varnish and falls under the regulation number 21 CFR 872.3260. The device is a type of fluoride varnish, which is applied to the teeth to help prevent tooth decay and sensitivity.

The Profluoro Fluoride Varnish is supplied by Pac-Dent International, Inc. and has been granted FDA 510(k) clearance, with the clearance type being traditional and the k number being K141422. The device is classified as a class II medical device, with product code LBH. It is intended for use in a dental setting and is regulated by the FDA, with a regulation number of 872.3260.

Frequently asked questions

What is the Profluoro Fluoride Varnish used for?

The Profluoro Fluoride Varnish is used for professional treatment of dental hypersensitivity by occluding dentinal tubules with an adherent film, helping prevent tooth decay and sensitivity.

Is the Profluoro Fluoride Varnish a single-use or reusable device?

The description does not explicitly state whether the Profluoro Fluoride Varnish is single-use or reusable, but as a dental varnish, it is typically applied in a clinical setting and may be used for multiple applications.

What is the regulatory classification of the Profluoro Fluoride Varnish?

The Profluoro Fluoride Varnish is classified as a class II medical device, with product code LBH, and is regulated by the FDA under regulation number 872.3260.

How is the Profluoro Fluoride Varnish supplied?

The Profluoro Fluoride Varnish is supplied by Pac-Dent International, Inc.

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: PROFLUORO FLUORIDE VARNISH (K141422) — FDA 510(k) | Innolitics, Profluoro Fluoride Varnish 510 (k) FDA Premarket Notification K141422 ..., fda.innolitics.com, Profluoro Fluoride Varnish - Beudamed

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Pac-Dent International, Inc.

Sources (1)

  • FDA 510(k) K141422 24 fields · synced Oct 6, 2026