# K051782: Bluephase 16I

- Pathway: 510(k) (Traditional)
- Applicant: Ivoclar Vivadent, Inc.
- Decided: Sep 20, 2005 after 81 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.
5 later devices descend from it; 1 cites it directly.
0 of 6 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
- K140432: HI-Light, HI-Light Plus (2015), 4 descendants of its own
- K170529: Delight, Delight ortho, B&Lite S (2017), 3 descendants of its own
- K253461: Demi Pro (2025), 0 descendants of its own
- K192233: LED Curing Light (2020), 0 descendants of its own
- K192009: LED Curing Light (2020), 0 descendants of its own

## Indications for use
For light curing polymerization of dental composites, luting materials, cements and other light cured materials.

Source page: https://510kreport.com/device/K051782
Methodology: https://510kreport.com/methodology