21 CFR 872.3820 — Resin, Root Canal Filling

Dental (DE) · Subpart D—Prosthetic Devices · § 872.3820

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.

Product Codes

Product CodeDevice NameClassDevicesAttributes
KIFResin, Root Canal Filling21433rd Party
MMTResin, Root Canal Filling Containing Chloroform30
NYDEndodontic Kit20
Innolitics

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