# K031615: Sled Curing Light System

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply International
- Decided: Jul 21, 2003 after 59 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: 2 generations back to K951425 (1995). 3 ancestors in all.
13 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982318: Spectrum 800 Curing Unit, Dentsply Intl. (1998) Summary page 2.
- K000393: Nova Cordless Curing Light, Nova/Da Vinci Systems, Inc. (2000) Summary page 1.

## Most influential descendants
- K041372: Smartlite PS Pen-Style Led Curing Light (2004), 12 descendants of its own
- K063529: Pencure, Model VL-7 (2007), 7 descendants of its own
- K071190: Root ZX II (2007), 6 descendants of its own
- K090925: Multiple (Apex Locator), Model RCM-7 (2009), 2 descendants of its own
- K151274: Dr's Finder (2016), 1 descendant of its own

## Indications for use
Curing camphorquinone-based visible light cured (VLC) materials

Source page: https://510kreport.com/device/K031615
Methodology: https://510kreport.com/methodology