# K181597: Le'Pen

- Pathway: 510(k) (Traditional)
- Applicant: Kmihh, Ltd.
- Decided: Apr 1, 2019 after 287 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: 3 generations back to K003383 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110582: Valo Cordless, Ultradent Products, Inc. (2011) Summary page 4.

## Indications for use
Source of illumination for curing photo-activated dental restorative materials and adhesives.

Source page: https://510kreport.com/device/K181597
Methodology: https://510kreport.com/methodology