# K121093: D1 Led Curing Light, Spec 3, Dentronix Led 3000

- Pathway: 510(k) (Abbreviated)
- Applicant: Dxm Co., Ltd.
- Decided: Nov 27, 2012 after 231 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 K961735 (1996). 9 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042703: Cybird Led Curing Light, Dxm Co., Ltd. (2004) Summary page 2.
- K040551: Coltolux Led Curing Light, Coltene/Whaledent, Inc. (2004) Summary page 2.
- K110582: Valo Cordless, Ultradent Products, Inc. (2011) Summary page 2.

## Most influential descendants
- K173876: Cybird LED Curing Light (2018), 1 descendant of its own
- K191221: Cybird LED Curing Light (2020), 0 descendants of its own
- K140281: Flexi-Lume Led System (2014), 0 descendants of its own

## Indications for use
The D1 LED Curing Light & accessories is intended to polymerize resinous dental materials, restorative composite materials, orthodontic brackets bonding and sealing materials that are photo-polymerized in the 430-490nm waveband of visible light.

Source page: https://510kreport.com/device/K121093
Methodology: https://510kreport.com/methodology