# K040614: Bluewand Led Dental Curing Wand System

- Pathway: 510(k) (Traditional)
- Applicant: J.L. Blosser, Inc.
- Decided: Apr 7, 2004 after 29 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: 1 generation back to K021797 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021797: L.E.Demetron, Sybron Dental Specialties, Inc. (2002) Summary page 1.

## Indications for use
The BlueWand TM LED Dental Curing Wand System is a cordless light intended for polymerization of visible light cured materials containing camphorquinone.

Source page: https://510kreport.com/device/K040614
Methodology: https://510kreport.com/methodology