# K253461: Demi Pro

- Pathway: 510(k) (Traditional)
- Applicant: Meta Systems Co., Ltd.
- Decided: Oct 14, 2025 after 7 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: 8 generations back to K003995 (2001). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220471: VALO X, VALO X Accessory Lenses, Ultradent Products, Inc. (2022) Summary page 5.
- K170529: Delight, Delight ortho, B&Lite S, Dentall Co., Ltd. (2017) Summary page 5.

## Indications for use
The Demi Pro is an LED visible light curing unit intended for polymerization of light-cured materials by dental professionals. It is also intended to provide illumination to aid in visualization during oral procedures.

Source page: https://510kreport.com/device/K253461
Methodology: https://510kreport.com/methodology