# K992102: Luma Light 2000 Cure Light

- Pathway: 510(k) (Traditional)
- Applicant: Lumalite, Inc.
- Decided: Aug 31, 1999 after 71 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K952333 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962376: Kreativ Kuring Light System, Kreativ, Inc. (1997) Summary page 1.
- K981948: Apollo 95E, Dental/Medical Diagnostic Systems, Inc. (1998) Summary page 1.
- K952333: Plasma Arc Curing System, American Dental Technologies, Inc. (1995) Summary page 1.

## Indications for use
The Luma Light 2000 Cure Light is a high intensity filtered light source, and optical delivery system, that produces curing of photo-activated dental composites or photo-activated bleaching formulations at four (4) times the rate of conventional light systems. The Luma Light 2000 Cure Light cures all photo activated dental materials such as those used in direct restorations, sealants, bonding agents and primers.

Source page: https://510kreport.com/device/K992102
Methodology: https://510kreport.com/methodology