Heliolux Ultraviolet Activator

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

Full name

Heliolux

510(k) Number

K913980 ↗

FDA Product Code

EBZ

Device Class

Class II

Regulation

21 CFR Part 872.6070

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• D-Sign VI (R&D Project DW266#9)

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  FDA 510(k) K990235 Active Cleared 1 Mar 1999

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  FDA 510(k) K011022 Active Cleared 2 May 2001

• Fermit N Plus

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  FDA 510(k) K003377 Active Cleared 4 Dec 2000

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  FDA 510(k) K993783 Active Cleared 13 Dec 1999

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  FDA 510(k) K910069 Active Cleared 2 Mar 1992

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  FDA 510(k) K896529 Active Cleared 16 Jan 1990

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• What is the primary purpose of the Heliolux Ultraviolet Activator in dental procedures?

  The Heliolux Ultraviolet Activator is designed specifically to polymerize composite resins and other light-cured materials in restorative dentistry. It emits ultraviolet radiation to initiate and accelerate the curing process, ensuring that dental restorations achieve optimal hardness and durability for long-term performance.

• Is the Heliolux Ultraviolet Activator intended for single-use or reusable applications?

  The Heliolux Ultraviolet Activator is supplied as a reusable instrument for use in dental offices and clinics. While it operates under non-sterile conditions, it must be cleaned and maintained properly to prevent cross-contamination between patients.

• What regulatory pathway was followed for the FDA clearance of the Heliolux Ultraviolet Activator?

  The Heliolux Ultraviolet Activator received FDA clearance through a traditional 510(k) pathway, classified as substantially equivalent to a predicate device. It holds clearance number K913980 and is categorized under Class II medical devices (21 CFR 872.6070), indicating it poses moderate risk and requires special controls beyond general controls.

• Are there multiple models or variations of the Heliolux Ultraviolet Activator available?

  The provided data lists multiple registration numbers (e.g., 2523990, 3038718579, etc.) associated with the Heliolux Ultraviolet Activator, which may correspond to different models or variations of the device. These identifiers are used for regulatory tracking but do not specify clinical differences. For exact specifications, consulting the manufacturer’s documentation or catalog would be necessary.