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Radiance Curing Light

FDA 510(k)

Class II (US FDA 510(k))

510(k) K982615

by Air Techniques, Inc.

Identifiers

510(k) Number
K982615 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 Radiance Curing Light is a dental ultraviolet activator designed for polymerizing light-cured restorative materials. It emits high-intensity light to cure composite resins and bonding agents during dental procedures, ensuring proper hardening of restorative materials in cavity preparations.

This device is intended for use in dental settings and is classified as a Class II medical device under FDA regulations (872.6070). It is supplied as a reusable instrument and requires no specific sterility conditions beyond standard dental practice protocols. The device is authorized under FDA 510(k) clearance (K982615) and is intended for single-patient use per session, adhering to dental hygiene standards. No MRI safety information is specified.

Frequently asked questions

What is the primary purpose of the Airdent Radiance Curing Light in a dental practice?

The Airdent Radiance Curing Light is designed specifically to polymerize light-cured restorative materials in dental procedures. It emits high-intensity ultraviolet light to harden composite resins and bonding agents within cavity preparations, ensuring proper curing for durable restorations.

Is the Airdent Radiance Curing Light intended for single-use or reusable applications?

The device is supplied as a reusable instrument, meaning it is designed for repeated use across multiple dental procedures. However, it is intended for single-patient use per session, adhering to standard dental hygiene protocols to maintain cleanliness and safety.

How is the Airdent Radiance Curing Light regulated, and what does that mean for its use?

The device is classified as a Class II medical device under FDA regulations (872.6070) and holds a 510(k) clearance (K982615). This means it has been determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets FDA safety and effectiveness standards for dental ultraviolet activators. Clinicians can rely on its regulatory clearance as confirmation of its intended use for curing light-activated materials in dental restorations.

Does the Airdent Radiance Curing Light require any special storage conditions?

The device does not specify any unique sterility or storage conditions beyond standard dental practice protocols. Since it is reusable, it should be cleaned and maintained according to manufacturer guidelines to ensure proper functionality and hygiene between uses.

Can the Airdent Radiance Curing Light be used with any type of dental restorative material?

The device is specifically intended for polymerizing light-cured restorative materials, such as composite resins and bonding agents. While it is designed to work with these materials, clinicians should always refer to the manufacturer’s instructions and the specific material’s guidelines to confirm compatibility and optimal curing results.

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: AIRDENT RADIANCE CURING LIGHT (K982615) — FDA 510(k) | Innolitics, Airdent Radiance Curing Light 510 (k) FDA Premarket Notification ..., PDF K982615 - Airdent Radiance Curing Light, Air Techniques, Inc. · DeviceClearance

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Air Techniques, Inc.

Sources (1)

  • FDA 510(k) K982615 24 fields · synced Sep 18, 2026