# K140281: Flexi-Lume Led System

- Pathway: 510(k) (Abbreviated)
- Applicant: Epic Medical Concepts & Innovations
- Decided: Jul 24, 2014 after 170 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 K961735 (1996). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121093: D1 Led Curing Light, Spec 3, Dentronix Led 3000, Dxm Co., Ltd. (2012) Summary page 1.

## Indications for use
The Flexi-Lume LED System is intended to polymerize dental materials, restorative composite materials, orthodontic brackets bonding and sealing materials that are photo-polymerized in the 430-490nm waveband of visible light. It is also intended to illuminate the patient's oral structures. It is also intended for bleaching procedures to apply light to a tooth after it is treated with a bleaching agent.

Source page: https://510kreport.com/device/K140281
Methodology: https://510kreport.com/methodology