G-BOND PLUS

• K Number: K082768
• Device Name: G-BOND PLUS
• Manufacturer: GC AMERICA, INC.
• Date Cleared: 2008-10-21 ( 29 days)
• Product Code: KLE
• Regulation Number: 872.3200
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

G-BOND PLUS is one-bottle typed light-cured bonding agent, and intended to be used for bonding light-cured composite resin to tooth.

Device Description

Not Found

AI/ML Overview

The provided document is an FDA 510(k) clearance letter for a dental bonding agent named "G-BOND PLUS." This document focuses on the regulatory authorization for marketing the device based on its substantial equivalence to a predicate device. It does not contain information regarding acceptance criteria for a specific performance study, the device's reported performance against such criteria, or details of a study that would demonstrate such performance (e.g., sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies with AI).

Therefore, I cannot answer your request based on the provided text. This document is a regulatory approval notice, not a scientific study report.

Regulation Number and Section

§ 872.3200 Resin tooth bonding agent.

(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.