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Celalux 3

FDA 510(k)

Class II (US FDA 510(k))

510(k) K153018

by VOCO GmbH

Identifiers

510(k) Number
K153018 FDA 510(k)
FDA Product Code
EBZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.6070 FDA 510(k)
Regulation Number
872.6070 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Celalux 3 is an ultraviolet activator for polymerizing dental materials, classified as a Class II dental device. It employs high-intensity LED technology to cure light-activated composites, resins, and adhesives used in restorative and adhesive dentistry, ensuring reliable polymerization for dental restorations.

This cordless, pen-shaped device features a lightweight design (70 g) and delivers a light intensity of approximately 1,300 mW/cm² within a wavelength range of 450–480 nm. It is intended for single-use applications in dental clinics and offices, with vibration feedback at 10-second and 20-second intervals to signal curing progress. The device holds an FDA 510(k) clearance under the classification of an activator, ultraviolet, for polymerization (K153018).

Frequently asked questions

What types of dental materials can the Celalux 3 ultraviolet activator cure, and how does its light intensity compare to other devices?

The Celalux 3 is designed to polymerize light-activated composites, resins, and adhesives commonly used in restorative and adhesive dentistry. Its high-intensity LED technology delivers approximately 1,300 mW/cm² within a wavelength range of 450–480 nm, ensuring reliable curing for these materials. While exact comparisons to other devices aren’t specified, this intensity is within the typical range for modern dental LED curing lights, providing efficient polymerization for dental restorations.

Is the Celalux 3 intended for single-use or repeated use in a clinical setting, and how does its design support this?

The Celalux 3 is explicitly designed for single-use applications in dental clinics and offices. Its lightweight, cordless, pen-shaped design (weighing 70 grams) and vibration feedback (at 10-second and 20-second intervals) suggest it is engineered for convenience and ease of use in a single procedure, reducing the risk of cross-contamination and simplifying inventory management.

What regulatory pathway was followed for FDA clearance of the Celalux 3, and what does this mean for clinicians?

The Celalux 3 received FDA 510(k) clearance under the classification of an *activator, ultraviolet, for polymerization* (K153018), with a substantially equivalent (SESE) determination. This means the device was reviewed by the FDA as meeting the performance criteria of a predicate device already on the market, ensuring it complies with safety and effectiveness standards for dental polymerization activators. Clinicians can rely on this clearance as evidence of regulatory scrutiny.

How does the Celalux 3’s vibration feedback feature improve the curing process for dental restorations?

The Celalux 3 includes vibration feedback at 10-second and 20-second intervals, which helps clinicians track the curing progress of light-activated materials. This feature ensures consistent exposure time, reducing the risk of incomplete polymerization—critical for the longevity and integrity of dental restorations. It also provides a tactile confirmation that the device is functioning as intended during use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Celalux 3 - Devices | VOCO GmbH, Celalux 3 - Devices | VOCO GmbH, Celalux 3 curing light - VOCO - dentaltix.com

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
VOCO GmbH

Sources (1)

  • FDA 510(k) K153018 24 fields · synced Oct 6, 2026