# K083647: Valo, Model 5919

- Pathway: 510(k) (Special)
- Applicant: Ultradent Products, Inc.
- Decided: Jan 23, 2009 after 45 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 K003383 (2001). 1 ancestor in all.
17 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003383: Palmlight, Ultradent Products, Inc. (2001) Summary page 1.

## Most influential descendants
- K110582: Valo Cordless (2011), 11 descendants of its own
- K190627: VALO Grand Corded (2019), 4 descendants of its own
- K210550: VALO Grand Corded and Accessory Lenses (2021), 3 descendants of its own
- K121093: D1 Led Curing Light, Spec 3, Dentronix Led 3000 (2012), 3 descendants of its own
- K220471: VALO X, VALO X Accessory Lenses (2022), 2 descendants of its own

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

Source page: https://510kreport.com/device/K083647
Methodology: https://510kreport.com/methodology