# K042196: Savedent Blue

- Pathway: 510(k) (Traditional)
- Applicant: Denfotex Light Systems, Ltd.
- Decided: Nov 1, 2004 after 80 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 summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K00154: Elipart Freelight. Number could not be read

## Indications for use
Light source for the activation of light cured resin polymers and glass ionomer materials used in dentistry as pit and fissure sealants, restorative materials, and bonding materials.

Source page: https://510kreport.com/device/K042196
Methodology: https://510kreport.com/methodology