FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

Class I and II restorations in deciduous teeth Non-load bearing Class I and II restorations in permanent teeth Immediate restorative and base material for heavy stress situation in Class I and II cavities using sandwich laminate technique Class V and root surface restorations Core build up

Device Description

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AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA to GC America, Incorporated for a dental cement called "GC Fuji IX GP EXTRA". This document is a regulatory approval and does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria as typically found in a clinical trial report or scientific publication for AI/ML devices.

Therefore, I cannot extract the requested information regarding acceptance criteria and study details. This document is a regulatory approval and does not describe technical performance metrics or how they were tested.

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K Number

K961448

Device Name

FUJI IX GP

Manufacturer

GC AMERICA, INC.

Date Cleared

1996-07-08

(83 days)

Product Code