# K081287: Sapphire Plasma Arc Dental Curing Light

- Pathway: 510(k) (Abbreviated)
- Applicant: Den-Mat Holdings, LLC
- Decided: Nov 21, 2008 after 198 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 K001719 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033795: Plasmacure Bxe, Eele Laboratories, LLC (2003) Summary page 1.

## Indications for use
The Sapphire PAC Light is a source of illumination for curing dental restorative materials and is a source of illumination for tooth whitening activities performed in dentistry.

Source page: https://510kreport.com/device/K081287
Methodology: https://510kreport.com/methodology