# K163064: Demi Ultra

- Pathway: 510(k) (Special)
- Applicant: Kerr Corporation
- Decided: Jul 18, 2017 after 258 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 K071251 (2007). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123468: Demi Ultra, Kerr Corporation (2013) Summary page 4.

## Indications for use
The Demi Ultra is a Light Emitting Diode (LED) visible light curing device used for the polymerization of light-cured materials by dental professionals.

Source page: https://510kreport.com/device/K163064
Methodology: https://510kreport.com/methodology