# K052122: Bisco Led

- Pathway: 510(k) (Traditional)
- Applicant: Bisco, Inc.
- Decided: Mar 29, 2006 after 236 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 K022862 (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)
- K022862: Transcure, Model 2910, Kinetic Instruments, Inc. (2002) Summary page 1.

## Indications for use
Bisco LED is a LED dental curing light.

Source page: https://510kreport.com/device/K052122
Methodology: https://510kreport.com/methodology