# K023545: Ultra-Lite 200E Light Cure Unit

- Pathway: 510(k) (Traditional)
- Applicant: Rolence Ent., Inc.
- Decided: Dec 30, 2002 after 69 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
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K040618: Led Turbo (2004), 4 descendants of its own
- K041303: Led Turbo-Pen (2004), 2 descendants of its own
- K071722: Deep Blue (2007), 0 descendants of its own
- K070373: Apoza Led Curing Light, Model E-Morlit, D-2000, Top 3W, Top 5W (2007), 0 descendants of its own
- K061695: Led Prolux 770 (2006), 0 descendants of its own

## Indications for use
THE ULTRA-LITE 200E IS A LIGHT CURE UNIT INTENDED FOR POLYMERIZATION OF LIGHT CURED MATERIAL BY DENTAL PROFESSIONALS.

Source page: https://510kreport.com/device/K023545
Methodology: https://510kreport.com/methodology