# K190627: VALO Grand Corded

- Pathway: 510(k) (Special)
- Applicant: Ultradent Products, Inc.
- Decided: Apr 29, 2019 after 48 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: 2 generations back to K003383 (2001). 2 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083647: Valo, Model 5919, Ultradent Products, Inc. (2009) Summary page 4.

## Most influential descendants
- K210550: VALO Grand Corded and Accessory Lenses (2021), 3 descendants of its own
- K220471: VALO X, VALO X Accessory Lenses (2022), 2 descendants of its own
- K253461: Demi Pro (2025), 0 descendants of its own
- K243921: LED Curing Lights (DB686 HALO) (2025), 0 descendants of its own

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

Source page: https://510kreport.com/device/K190627
Methodology: https://510kreport.com/methodology