# K071722: Deep Blue

- Pathway: 510(k) (Traditional)
- Applicant: E.M.S Electro Medical Systems S.A
- Decided: Aug 10, 2007 after 49 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: 3 generations back to K023545 (2002). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032465: Mini L.E.D., Model: Mini L.E.D., Model Smartlite Mini, Satelec (2003) Summary page 1.
- K041303: Led Turbo-Pen, Apoza Enterprise Co., Ltd. (2004) Summary page 1.

## Indications for use
The Deep Blue ® is a dental curing light that is intended for use in dental procedures requiring the photopolymerization of materials.

Source page: https://510kreport.com/device/K071722
Methodology: https://510kreport.com/methodology