# K210550: VALO Grand Corded and Accessory Lenses

- Pathway: 510(k) (Traditional)
- Applicant: Ultradent Products, Inc.
- Decided: Mar 1, 2021 after 4 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: 6 generations back to K003995 (2001). 13 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190627: VALO Grand Corded, Ultradent Products, Inc. (2019) Summary page 5.
- K101140: Dentlight Oral Exam Light Kit, Dentlight, Inc. (2010) Summary page 5.

## Most influential descendants
- 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
Source of illumination for curing photo-activated dental restorative materials and adhesives. The VALO Accessory Lenses are multiple-use accessory lenses intended to provide illumination to aid in visualization during oral procedures and augment the VALO family of curing lights, which are a source of illumination for curing photo-activated dental restorative materials and adhesives. VALO Accessory Lenses are not intended for complete cure of photo-activated materials and adhesives.

Source page: https://510kreport.com/device/K210550
Methodology: https://510kreport.com/methodology