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e-CFR data is current as of February 23, 2021

Title 21Chapter ISubchapter HPart 872Subpart E → §872.4920

Title 21: Food and Drugs
Subpart E—Surgical Devices

§872.4920   Dental electrosurgical unit and accessories.

(a) Identification. A dental electrosurgical unit and accessories is an AC-powered device consisting of a controlled power source and a set of cutting and coagulating electrodes. This device is intended to cut or remove soft tissue or to control bleeding during surgical procedures in the oral cavity. An electrical current passes through the tip of the electrode into the tissue and, depending upon the operating mode selected, cuts through soft tissue or coagulates the tissue.

(b) Classification. Class II.

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