# K033520: Bluephase

- Pathway: 510(k) (Traditional)
- Applicant: Ivoclar Vivadent, Inc.
- Decided: Dec 5, 2003 after 28 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K071908: Doctor's Light Led Dental Curing Light (2007), 0 descendants of its own

## Indications for use
Bluephase® is a hand held LED polymerization light intended to cure dental composites using visible light.

Source page: https://510kreport.com/device/K033520
Methodology: https://510kreport.com/methodology