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K Number
K150128
Device Name
GC Ortho Connect, GC Ortho Etching Gel
Manufacturer
GC Orthodontics America Inc.
Date Cleared
2015-07-16

(177 days)

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

GC Ortho Connect

    1. Bonding metal brackets and attachments
    1. Bonding ceramic brackets
    1. Bonding plastic brackets and acrylic appliances

GC Ortho Etching Gel

    1. Etching enamel of tooth surfaces
    1. Enhancing the bond strength of light-cured orthodontic adhesive materials
Device Description

Not Found

AI/ML Overview

This document is an FDA 510(k) clearance letter for two dental products: GC Ortho Connect and GC Ortho Etching Gel. It does not contain information about acceptance criteria or a study proving that the device meets those criteria. The letter primarily states that the devices are substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide 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.