MMT · Resin, Root Canal Filling Containing Chloroform

Dental · 21 CFR 872.3820 · Class 3

Overview

Product CodeMMT
Device NameResin, Root Canal Filling Containing Chloroform
Regulation21 CFR 872.3820
Device ClassClass 3
Review PanelDental

Identification

A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.

Classification Rationale

(1) Class II if chloroform is not used as an ingredient in the device.(2) Class III if chloroform is used as an ingredient in the device.

Recent Cleared Devices (0 of 0)

No cleared devices on record.

Innolitics

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