ArthroCare Dental Electrosurgery System

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K962445 ↗

FDA Product Code

EKZ

Device Class

Class II

Regulation

21 CFR Part 872.4920

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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• Arthrocare Arthroscopic Eletrosurgery System (Model 980)

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• Modification to Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord, Arthrowands and Spine Wands

  Class II

  FDA 510(k) K000511 Active Cleared 13 Mar 2000

See all devices from ArthroCare Corporation →

• What types of dental procedures is the ArthroCare Dental Electrosurgery System intended for?

  The system is designed for dental and periodontal procedures where controlled radiofrequency energy is used to remove soft tissue and achieve haemostasis in the oral cavity. This includes applications requiring surgical precision, such as gingival reshaping, frenectomy, or other soft tissue surgeries, but it is not intended for hard tissue procedures like bone cutting.

• Is the ArthroCare Dental Electrosurgery System reusable or single-use, and what maintenance does it require?

  The system is supplied as a reusable medical device, meaning it is intended for repeated use in dental offices and clinics. It requires proper maintenance and sterilization procedures as outlined by the manufacturer to ensure safety and functionality between uses, as it is not sterile upon delivery.

• How is the device regulated, and what does the product code EKZ indicate?

  The device is regulated under FDA 510(k) clearance with the specific clearance number K962445, and it adheres to FDA regulation 872.4920. The product code EKZ categorizes it as an electrosurgical unit and accessories, specifically for dental use, under the Dental (DE) advisory committee classification.

• Can this device be used in an MRI environment, and what safety considerations should be noted?

  The device is explicitly not classified as MRI-safe, meaning it should not be used in or near MRI environments. Clinicians should follow manufacturer guidelines to ensure safe operation, including proper grounding and avoiding exposure to magnetic fields, as the system relies on radiofrequency energy.

• What should a buyer consider regarding the device’s compatibility with existing dental equipment?

  The system is designed for integration into standard dental office settings but requires adherence to manufacturer specifications for electrical compatibility and safety. Buyers should verify that their facility’s electrical infrastructure meets the system’s power requirements and that proper training is provided for staff to operate it safely alongside other dental tools.