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Bosworth Copalioner

FDA 510(k)

Class II (US FDA 510(k))

510(k) K933505

by Harry J. Bosworth Co.

Identifiers

510(k) Number
K933505 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 Bosworth Copaliner is a cavity varnish (FDA classification: Varnish, Cavity), designed to protect and seal dentinal tubules in prepared cavities. It is an ether-based dental varnish intended to act as a barrier against bacterial penetration, moisture, and thermal shock, thereby supporting the longevity of restorative materials.

Supplied as a complete set containing varnish and solvent, the Copaliner is intended for single-use in dental procedures. It is not sterile but is packaged for aseptic handling in clinical settings. The device is classified as Class II under FDA regulations (21 CFR 872.3260) and holds a FDA 510(k) clearance (K933505) for dental applications. No MRI safety information is specified, and storage conditions are not detailed in the regulatory data.

Frequently asked questions

What is the primary purpose of the Bosworth Copaliner in dental procedures?

The Bosworth Copaliner is designed as a cavity varnish to protect and seal dentinal tubules in prepared cavities. Its main function is to act as a barrier against bacterial penetration, moisture, and thermal shock, which helps support the longevity of restorative dental materials.

Is the Bosworth Copaliner intended for single-use or repeated use in a clinical setting?

The Bosworth Copaliner is explicitly intended for single-use in dental procedures. Each set contains varnish and solvent, and it is not designed for reuse.

How should the Bosworth Copaliner be handled in terms of sterility during use?

The Bosworth Copaliner is not sterile but is packaged to allow for aseptic handling in clinical settings. This means it should be opened and used under sterile conditions, such as in a clean field or using sterile instruments.

What regulatory pathway was followed for the FDA clearance of the Bosworth Copaliner?

The Bosworth Copaliner received FDA clearance through a traditional 510(k) pathway, with a clearance number of K933505. It was determined to be substantially equivalent to a predicate device and falls under the classification of Class II (21 CFR 872.3260) for dental applications.

Are there any specific storage instructions provided for the Bosworth Copaliner in the regulatory data?

The regulatory data for the Bosworth Copaliner does not specify storage conditions, so it is important to follow the manufacturer’s instructions or general best practices for handling dental varnishes to ensure optimal performance and safety.

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: BOSWORTH COPALIONER (K933505) — FDA 510 (k) | Innolitics, Bosworth Copalioner 510 (k) FDA Premarket Notification K933505 HARRY J ..., Copaliner 0921525 Varnish & Sealant - Henry Schein Dental, PDF K933505 - Bosworth Copalioner, Harry J. Bosworth Co. - FDA 510 (k) Cleared Devices

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Harry J. Bosworth Co.

Sources (1)

  • FDA 510(k) K933505 24 fields · synced Oct 6, 2026