GC MODELS OPA-100 AND JC-50 by GC AMERICA, INC. | FDA 510(k) Summary

FDA 510(k) Search

K Number

Device Name

GC MODELS OPA-100 AND JC-50

Manufacturer

GC AMERICA, INC.

Date Cleared

2008-02-15

(57 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

AI/ML Overview

Summary

Regulation Number and Section

§ 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.