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K Number
K981461
Device Name
GC FUJI ORTHO LC
Manufacturer
GC AMERICA, INC.
Date Cleared
1998-06-25

(63 days)

Product Code
DYH
Regulation Number
872.3750
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

GC Fuji Ortho LC is a glass ionomer dental cement designed for use as an orthodontic adhesive for brackets, bands and bonded appliances.

Device Description

GC Fuji Ortho LC is a glass ionomer dental cement.

AI/ML Overview

This document is an FDA 510(k) clearance letter for a dental cement. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria as typically found in a performance study report for an AI/ML device. Therefore, I cannot extract the requested information from this document.

§ 872.3750 Bracket adhesive resin and tooth conditioner.

(a)
Identification. A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.(b)
Classification. Class II.