# K052593: Fusion Curing Light

- Pathway: 510(k) (Traditional)
- Applicant: Dentlight, Inc.
- Decided: Sep 28, 2005 after 7 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 K951425 (1995). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041372: Smartlite PS Pen-Style Led Curing Light, Dentsply International (2004) Summary page 1.
- K030568: RADII, Southern Dental Industries, Inc. (2003) Summary page 1.

## Indications for use
The FUSION Curing Light is a dental curing light that is intended for photopolymerization of dental resins, restorative composite materials, and orthodontic brackets, bonding, and sealing that are photo-polymerized in the 440-480 nm wavelength range.

Source page: https://510kreport.com/device/K052593
Methodology: https://510kreport.com/methodology