# K020057: Palmlight

- Pathway: 510(k) (Traditional)
- Applicant: CAO Group, Inc.
- Decided: Aug 27, 2002 after 231 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Ultradent Palmlight: named in the summary without a submission number
- (no number) Jetlite 4000: named in the summary without a submission number

## Indications for use
A source of illumination for curing photo-activated dental restorative materials, adhesives, pit and fissure sealants and activating tooth whitening materials via a light emitting diode (LED).

Source page: https://510kreport.com/device/K020057
Methodology: https://510kreport.com/methodology