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American Dental Laser Single Use Contact 320 Handp

by American Dental Laser, Inc.

510(k) K923539

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK923539 Date28 Oct 1992ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
GEX
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
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 American Dental Laser Single Use Contact 320 Handp is a medical device designed for use in laser procedures. It functions as a contact handpiece to facilitate the delivery of laser energy during clinical applications.

This device is supplied as a single-use component. It has received FDA 510(k) clearance under the product code GEX.

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 primary function of the American Dental Laser 320 Handpiece?

    This device serves as a contact handpiece specifically engineered to facilitate the delivery of laser energy during various clinical laser procedures.

  • Is the American Dental Laser 320 Handpiece intended for multiple uses?

    No, this device is supplied as a single-use component. It is designed to be used once to ensure clinical safety and performance standards are maintained for each procedure.

  • What is the regulatory status of this handpiece?

    The American Dental Laser Single Use Contact 320 Handpiece has received FDA 510(k) clearance under the product code GEX, confirming it is substantially equivalent to legally marketed predicate devices.