# K041372: Smartlite PS Pen-Style Led Curing Light

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply International
- Decided: Jun 24, 2004 after 31 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 K951425 (1995). 4 ancestors in all.
12 later devices descend from it; 5 cite 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)
- K031615: Sled Curing Light System, Dentsply International (2003) Summary page 1.
- K982318: Spectrum 800 Curing Unit, Dentsply Intl. (1998) Summary page 1.

## Most influential descendants
- 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
- K112665: Tri Auto Mini - Endodeontic Treatment Motorized Handpiece (2012), 1 descendant of its own

## Indications for use
The SmartLiteTM PS Pen-Style LED Curing Light is indicated for curing campliorquinone-based visible light cured (VLC) dental materials

Source page: https://510kreport.com/device/K041372
Methodology: https://510kreport.com/methodology