Avante Led Curing Unit, Model N44

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

510(k) Number

K052349 ↗

FDA Product Code

EBZ

Device Class

Class II

Regulation

21 CFR Part 872.6070

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K023819 Active Cleared 26 Mar 2003

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  FDA 510(k) K023818 Active Cleared 3 Apr 2003

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  FDA 510(k) K060889 Active Cleared 27 Oct 2006

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See all devices from Pentron Clinical Technologies →

• What is the primary function of the Avante LED Curing Unit?

  The Avante LED Curing Unit is a dental device designed to polymerize dental restorative resins. It functions as an ultraviolet activator that uses light-emitting diode technology to emit light at a 470nm peak to cure these materials.

• How is the device operated during dental procedures?

  The device is designed as a cordless and compact unit to facilitate ease of use in a clinical setting. It includes user-selectable timer settings that allow the operator to adjust the curing duration between 1 and 40 seconds based on the specific requirements of the restorative procedure.

• What is the regulatory status of this curing unit?

  The Avante LED Curing Unit, Model N44, is regulated as a Class II dental device under 21 CFR 872.6070. It has received FDA 510(k) clearance, which indicates it has been reviewed and found to be substantially equivalent to legally marketed predicate devices.