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Aegis Ortho Dual-Cured Orthodontic Adhesive

FDA 510(k)

Class II (US FDA 510(k))

510(k) K040547

by Harry J. Bosworth Co.

Identifiers

510(k) Number
K040547 FDA 510(k)
FDA Product Code
DYH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3750 FDA 510(k)
Regulation Number
872.3750 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Aegis Ortho Dual-Cured Orthodontic Adhesive is a filled, two-component, dual-cure resin adhesive used by dental professionals for bonding orthodontic brackets/bands and cementing dental restorations. It operates via light-activation or chemical-cure, with the chemical-cure mode utilized when bracket opacity prevents sufficient light exposure.

The adhesive is supplied for use in clinical dental settings to facilitate secure attachment of orthodontic appliances. It contains amorphous calcium phosphate (ACP), which accelerates the calcium phosphate remineralization process of the teeth. The device is FDA 510(k) cleared with product code DYH and is classified as a Class II device.

Frequently asked questions

What is Aegis Ortho Dual-Cured Orthodontic Adhesive used for?

Aegis Ortho Dual-Cured Orthodontic Adhesive is used by dental professionals for bonding orthodontic brackets/bands and cementing dental restorations. It contains amorphous calcium phosphate (ACP) which accelerates the calcium phosphate remineralization process of teeth.

How is Aegis Ortho Dual-Cured Orthodontic Adhesive activated?

The adhesive operates via dual-cure mechanism, utilizing either light-activation or chemical-cure. The chemical-cure mode is specifically used when bracket opacity prevents sufficient light exposure during the bonding process.

What is the regulatory classification of Aegis Ortho Dual-Cured Orthodontic Adhesive?

The device is FDA 510(k) cleared with product code DYH and is classified as a Class II device. It received substantial equivalence determination on March 19, 2004, with K number K040547.

How is Aegis Ortho Dual-Cured Orthodontic Adhesive supplied?

The adhesive is supplied as a two-component system for use in clinical dental settings to facilitate secure attachment of orthodontic appliances. The specific packaging details are not provided in the available information.

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: Aegis Ortho Dual-cured Orthodontic Adhesive, Aegis ORTHO - Dental Advisor, AEGIS ORTHO DUAL-CURED ORTHODONTIC ADHESIVE 510(k) K040547 - fda.report

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) K040547 24 fields · synced Oct 6, 2026