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K Number
K041471
Device Name
G-BOND
Manufacturer
GC AMERICA INC.
Date Cleared
2004-06-29

(27 days)

Product Code
KLE
Regulation Number
872.3200
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

This product is a light-cured dentin bonding agent to provide effective bonding to resin composite restorative materials.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a dental bonding agent called "G-BOND." It does not contain information about acceptance criteria or a study proving that an AI device meets acceptance criteria. The document is strictly about the regulatory clearance of a medical device (a resin tooth bonding agent) and does not involve AI or any performance study as described in your request.

Therefore, I cannot provide the requested information based on the provided text.

§ 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.