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HILUX 200, 250, 275, 300, 350, 500 Dental Curing Light

by Benlioglu Dental Ithalat, Inc.

510(k) K970506

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 NumberK970506 Date4 Jun 1997ClearedStatusActive

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  • Withdrawn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
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 HILUX 200, 250, 275, 300, 350, 500 Dental Curing Light is an activator, ultraviolet device for polymerization used in dental applications. It is designed to cure dental materials through ultraviolet light activation.

The device is supplied by Benlioglu Dental Ithalat, Inc. and has FDA 510(k) clearance with the K number K970506. It is classified as Class II under product code EBZ with special controls. The device is available in multiple models including 200, 250, 275, 300, 350, and 500.

Questions

AI-generated answers, 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.

  • What is the HILUX Dental Curing Light used for?

    The HILUX Dental Curing Light is an activator, ultraviolet device for polymerization used in dental applications. It is designed to cure dental materials through ultraviolet light activation.

  • How is the HILUX Dental Curing Light supplied?

    The device is supplied by Benlioglu Dental Ithalat, Inc. and is available in multiple models including 200, 250, 275, 300, 350, and 500. Each model may have specific features or capabilities tailored to different dental applications.

  • What is the regulatory status of the HILUX Dental Curing Light?

    The HILUX Dental Curing Light has FDA 510(k) clearance with the K number K970506. It is classified as Class II under product code EBZ with special controls, indicating it meets specific regulatory requirements for safety and effectiveness.

  • Is the HILUX Dental Curing Light reusable or single-use?

    The device information does not specify whether the HILUX Dental Curing Light is designed for single-use or multiple uses. This detail would typically be found in the product's instructions for use, which should be consulted for proper handling and sterilization procedures.