21 C.F.R. § 872.4920 Dental electrosurgical unit and accessories.
Title 21 - Food and Drugs
(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.
Title 21: Food and Drugs
PART 872—DENTAL DEVICES
Subpart E—Surgical Devices
§ 872.4920 Dental electrosurgical unit and accessories.
