# K110756: Bluephase Style

- Pathway: 510(k) (Traditional)
- Applicant: Ivoclar Vivadent, Inc.
- Decided: Aug 29, 2011 after 164 days
- Product code: EBZ (Activator, Ultraviolet, For Polymerization)
- Device class: 2
- Regulation: 21 CFR 872.6070
- Recalls of this device: 1 (0 Class I)
- 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 no predicate by number.

## Recalls of this device
- Apr 14, 2014 · Class II · Z-1740-2014: A stock check revealed broken glass fibers between the connector and the fiber bundle in a large number of these light probes.

## Indications for use
For light curing polymerization of light-curing dental materials curing in the wavelength range of 385-515 nm. These materials include restoratives, bonding agentsladhesives, bases, liners, fissure sealants, temporaries, as well as luting mateirals for brackets and indirect restorations, such as ceramic inlays.

Source page: https://510kreport.com/device/K110756
Methodology: https://510kreport.com/methodology