# K200809: D-LUX+

- Pathway: 510(k) (Traditional)
- Applicant: DiaDent Group International
- Decided: Aug 7, 2020 after 133 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: 3 generations back to K091020 (2009). 3 ancestors in all.
7 later devices descend from it; 4 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190272: Bluephase PowerCure, Ivoclar Vivadent, AG (2019) Summary page 4.

## Most influential descendants
- K220826: LED Curing Light (2022), 2 descendants of its own
- K221152: CuringPen Dental Curing Light (2022), 1 descendant of its own
- K253131: Curing Light (M-Cure 6) (2026), 0 descendants of its own
- K242386: Bluemoon (2025), 0 descendants of its own
- K243921: LED Curing Lights (DB686 HALO) (2025), 0 descendants of its own

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

Source page: https://510kreport.com/device/K200809
Methodology: https://510kreport.com/methodology