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K Number
K033808
Device Name
GRADIA GUM
Manufacturer
GC AMERICA, INC.
Date Cleared
2004-02-02

(56 days)

Product Code
EBF
Regulation Number
872.3690
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

GRADIA GUM is a light-cured composite resin specifically used for the reproduction of the gum on crown and bridge prostheses.

Device Description

GRADIA GUM is a light-cured composite resin.

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a dental device called GRADIA GUM. It does not contain information about acceptance criteria or a study proving that the device meets those criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information from this document.

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.