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Nupro Model 13016901 Cavity Varnish

FDA 510(k)

Class II (US FDA 510(k))

510(k) K103160

by Cao Group, Inc.

Identifiers

510(k) Number
K103160 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 Nupro Model 13016901 is an ethanol-based cavity varnish containing sodium fluoride (5% NaF, 22,600 ppm fluoride ion). Classified as a Varnish, Cavity under FDA regulation 872.3260, this device is designed to protect intact tooth surfaces or exposed dentin prior to temporary restorations. Its formulation combines fluoride for remineralisation with an ethanol base for application consistency.

This device is supplied as a single-use, non-sterile dental product intended for professional use in clinical settings. It is classified under FDA Class II and has received FDA 510(k) clearance (K103160) as substantially equivalent to a predicate device. Storage conditions are not specified in the data, but typical ethanol-based varnishes require protection from extreme temperatures and light. The product is regulated under the Dental advisory committee and is distributed under product code LBH.

Frequently asked questions

What is the primary purpose of the Nupro Model 13016901 in dental procedures?

The Nupro Model 13016901 is an ethanol-based cavity varnish containing sodium fluoride (5% NaF, 22,600 ppm fluoride ion) designed to protect intact tooth surfaces or exposed dentin before temporary restorations. Its fluoride content supports remineralization, while the ethanol base ensures smooth application.

Is this product single-use or reusable, and what are the implications for clinical workflow?

The Nupro Model 13016901 is explicitly labeled as a single-use dental product, meaning each application requires a new unit. This design reduces cross-contamination risk and ensures consistent performance, as reuse could compromise sterility or formulation integrity.

What storage conditions should be followed for this varnish to maintain its efficacy?

While specific storage instructions aren’t detailed, ethanol-based varnishes like this typically require protection from extreme temperatures and direct light. Storing it in a cool, dry place away from heat sources and UV exposure will help preserve its stability and application consistency.

How was the regulatory pathway for this device determined, and what does that mean for clinicians?

The Nupro Model 13016901 received FDA 510(k) clearance (K103160) under the Traditional pathway, classified as substantially equivalent to a predicate device. This means it underwent FDA review by the Dental Advisory Committee (DE) and was determined to meet the same performance standards as existing cavity varnishes, ensuring its safety and effectiveness for professional dental use.

Is this product sterile, and if not, what precautions should be taken during use?

The Nupro Model 13016901 is explicitly labeled as non-sterile. Since it’s intended for professional use, clinicians should follow standard aseptic techniques—such as using sterile applicators or gloves—and avoid contaminating the product before application to minimize infection risks.

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: Nupro Model 13016901 - Beudamed, NUPRO MODEL 13016901 510 (k) K103160 - FDA.report, NUPRO MODEL 13016901 (K103160) — FDA 510 (k) | Innolitics, PDF K103160 - Nupro Model 13016901

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cao Group, Inc.

Sources (1)

  • FDA 510(k) K103160 24 fields · synced Sep 19, 2026