# K012134: GC E-Light

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Aug 7, 2001 after 29 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
No predicates in its family tree.
12 later devices descend from it; 1 cites 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K032465: Mini L.E.D., Model: Mini L.E.D., Model Smartlite Mini (2003), 11 descendants of its own
- K042703: Cybird Led Curing Light (2004), 5 descendants of its own
- K121093: D1 Led Curing Light, Spec 3, Dentronix Led 3000 (2012), 3 descendants of its own
- K173876: Cybird LED Curing Light (2018), 1 descendant of its own
- K072181: Mini Led Autofocus (2007), 1 descendant of its own

## Indications for use
Source of illumination for curing visible light cured dental materials such as composites, bonding agents and glass ionomer cements.

Source page: https://510kreport.com/device/K012134
Methodology: https://510kreport.com/methodology