LogoFDA 510(k) Search
K Number
K080478
Device Name
GRADIA FORTE
Manufacturer
GC AMERICA, INC.
Date Cleared
2008-06-05

(104 days)

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

GRADIA FORTE is intended to be used for the indirect restoration of crown & bridge, inlays, veneers and implant superstructures.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria, study details, performance metrics, sample sizes, expert qualifications, or ground truth establishment for the GRADIA FORTE device. The document is a 510(k) clearance letter from the FDA, which primarily states that the device is substantially equivalent to a legally marketed predicate device for its indicated uses. It does not contain the kind of detailed study breakdown you've requested.

§ 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.