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Pulpdent Fluoride Varnish

FDA 510(k)

Class II (US FDA 510(k))

510(k) K093620

by Pulpdent Corporation

Identifiers

510(k) Number
K093620 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)

A dental cavity varnish designed to prevent enamel lesions by delivering fluoride, calcium, and phosphate ions. It is formulated as a protective coating applied directly to tooth surfaces to remineralize and strengthen enamel, reducing the progression of early caries.

Supplied as a single-use, non-sterile product for in-office application by dental professionals. The varnish is classified as a Class II medical device under FDA regulations (FDA_510K, K093620) and is intended for use in dental settings. Storage instructions are not specified in the data, but typical dental varnishes require protection from moisture and extreme temperatures. No MRI safety or reusable specifications are noted.

Frequently asked questions

What is the primary purpose of the Pulpdent Fluoride Varnish, and how does it work?

The Pulpdent Fluoride Varnish is designed to prevent enamel lesions by delivering fluoride, calcium, and phosphate ions directly to tooth surfaces. It acts as a protective coating that remineralizes and strengthens enamel, helping to slow or stop the progression of early cavities. The varnish is applied in-office by dental professionals as a preventive measure for patients at risk of dental caries.

Is the Pulpdent Fluoride Varnish intended for single-use or reusable applications?

The Pulpdent Fluoride Varnish is explicitly supplied as a single-use product, meaning each application requires a new unit. This ensures sterility and hygiene, as it is not intended for reuse or reprocessing.

How should the Pulpdent Fluoride Varnish be stored, and are there any special handling requirements?

While specific storage instructions are not detailed in the data, dental varnishes like this typically require protection from moisture and extreme temperatures to maintain efficacy. It should be stored in a dry, sealed environment, away from direct sunlight or heat sources, to preserve its formulation until use.

What regulatory pathway was followed for FDA clearance of the Pulpdent Fluoride Varnish?

The Pulpdent Fluoride Varnish was cleared through the FDA’s 510(k) Traditional pathway, determined to be substantially equivalent to a predicate device. The submission was reviewed by the Dental (DE) Advisory Committee and classified as a Class II medical device under regulation number 872.3260. The clearance was granted on March 10, 2010, following a decision code of SESE (Substantially Equivalent Substantial Equivalence).

Can the Pulpdent Fluoride Varnish be used in patients with metal implants or during MRI procedures?

The data does not specify any MRI safety considerations or restrictions for use with metal implants. However, since it is a dental varnish applied topically to teeth, there is no inherent risk to metallic dental work or MRI compatibility. Clinicians should still follow standard protocols for patients with implants or undergoing MRI scans, as other factors may apply.

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: Embrace™ Varnish - PULPDENT, Embrace™ Varnish - PULPDENT, Embrace Varnish: Timed-release fluoride varnish for superior ... - PULPDENT, Amazon.com: Pulpdent Corp Pulpdent FVT Embrace Varnish 5% Sodium ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Pulpdent Corporation

Sources (1)

  • FDA 510(k) K093620 24 fields · synced Sep 18, 2026