# K223414: Curing Light, Model: MaxCure 9

- Pathway: 510(k) (Traditional)
- Applicant: Guilin Refine Medical Instrument Co., Ltd.
- Decided: Nov 15, 2023 after 370 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: 4 generations back to K091020 (2009). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200809: D-LUX+, DiaDent Group International (2020) Summary page 5.

## Indications for use
The MaxCure9 is intended to polymerize resinous dental materials, restorative composite materials, and orthodontic brackets, bonding and sealing materials that are photo-polymerized in the 385~515nm waveband of visible light.

Source page: https://510kreport.com/device/K223414
Methodology: https://510kreport.com/methodology