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K Number
K052462
Device Name
G-COAT
Manufacturer
GC AMERICA, INC.
Date Cleared
2005-10-20

(42 days)

Product Code
EBD
Regulation Number
872.3310
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

To seal the surface of direct composite and glass-ionomer restorations, indirect composite restorations, provisional restorations and their adhesive interface of margin to enamel or dentin.

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, or device performance metrics for the G-Coat device. The given text is primarily a 510(k) clearance letter from the FDA, which confirms that the device is substantially equivalent to legally marketed devices and can be marketed. It does not contain the detailed technical or clinical study data that would include acceptance criteria, sample sizes, ground truth establishment, or multi-reader multi-case study results.

§ 872.3310 Coating material for resin fillings.

(a)
Identification. A coating material for resin fillings is a device intended to be applied to the surface of a restorative resin dental filling to attain a smooth, glaze-like finish on the surface of the filling.(b)
Classification. Class II.