# K033795: Plasmacure Bxe

- Pathway: 510(k) (Traditional)
- Applicant: Eele Laboratories, LLC
- Decided: Dec 19, 2003 after 14 days
- Product code: EBZ (Activator, Ultraviolet, For Polymerization)
- Device class: 2
- Regulation: 21 CFR 872.6070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K001719 (2000). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024374: Rmo Plasma Curing Light, Lokki Lasers Medicaux (2003) Summary page 2.
- K001719: Q-Lux Plasma 100 Light Cure Unit, Rolence Enterprise Co., Ltd. (2000) Summary page 2.
- K020091: Optilux 501, Kerr Corporation (Danbury) (2002) Summary page 2.

## Most influential descendants
- K081287: Sapphire Plasma Arc Dental Curing Light (2008), 0 descendants of its own

## Indications for use
The PlasmaCure BXe Curing Light is a source of illumination for curing dental restorative materials and is a source of illumination for tooth whitening activities performed in dentistry.

Source page: https://510kreport.com/device/K033795
Methodology: https://510kreport.com/methodology