BONART ART-E1 ELECTROSURGERY UNIT

• K Number: K020080
• Device Name: BONART ART-E1 ELECTROSURGERY UNIT
• Manufacturer: DIAGNOSTIC DATA, INC.
• Date Cleared: 2002-02-19 ( 41 days)
• Product Code: EKZ
• Regulation Number: 872.4920
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

The Bonart Co., Ltd. ART-E1 Electrosurgery Unit is intended for use in dental electrosurgery (electrosection), electrosection/electrocoagulation, and electrocoagulation for serious bleeding.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification letter from the FDA regarding an electrosurgery unit. It does not contain information about acceptance criteria, device performance, study details (sample size, data provenance, ground truth, expert qualifications, adjudication methods), or AI-related comparative effectiveness or standalone studies.

Therefore, I cannot provide the requested information based on the provided text. This document is a regulatory approval letter, not a study report.

Regulation Number and Section

§ 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.