Sirius Max Dental Diode Curing Light

by National Dental, Inc.

510(k) K152936

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

510(k) K152936↗

FDA record

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

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK152936	Date13 Nov 2015Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K152936
FDA Product Code: EBZ

Device Class: Class II
Regulation: 21 CFR Part 872.6070
Advisory Committee: Dental
FDA Decision: SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

The Sirius Max Dental Diode Curing Light is a battery-operated, handheld dental device used by clinicians to polymerize restorative materials and adhesives. It utilizes a solid-state LED module to emit high-intensity light for curing and a separate white light LED for intraoral transillumination.

The device is supplied as a reusable, cordless system designed for use in dental office settings. It is classified as a Class II medical device under FDA regulation number 872.6070 and holds FDA 510(k) clearance K152936.