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Electrosurgical Electrode

by Premier

510(k) K925116

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK925116 Date1 Mar 1994ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
EKZ
Device Class
Class II
Regulation
21 CFR Part 872.4920
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Electrosurgical Electrode is a medical device used in dental procedures for electrosurgical applications. It is designed to perform cutting and coagulation functions during surgical interventions.

This electrode is supplied as a disposable item and is available in various sizes including 1x1cm and 2x8cm. It is regulated under FDA 510K clearance with product code EKZ and is intended for use in dental settings.

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Electrosurgical Electrode used for?

    The Electrosurgical Electrode is designed for dental procedures to perform cutting and coagulation functions during surgical interventions. It is specifically intended for use in dental settings.

  • Is the Electrosurgical Electrode reusable or single-use?

    The Electrosurgical Electrode is supplied as a disposable item, meaning it is designed for single-use only. This ensures sterility and optimal performance during each procedure.

  • What sizes are available for the Electrosurgical Electrode?

    The Electrosurgical Electrode is available in various sizes including 1x1cm and 2x8cm to accommodate different procedural needs in dental settings.

  • What is the regulatory status of this device?

    The Electrosurgical Electrode is regulated under FDA 510K clearance with product code EKZ. It received traditional clearance in 1994 and is classified as a Class II device.