# K091020: Bluephase 20I

- Pathway: 510(k) (Traditional)
- Applicant: Ivoclar Vivadent, Inc.
- Decided: Jun 12, 2009 after 64 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.
11 later devices descend from it; 2 cite it directly.
0 of 12 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
- K163613: Bluephase Style 20i (2017), 9 descendants of its own
- K190272: Bluephase PowerCure (2019), 8 descendants of its own
- K200809: D-LUX+ (2020), 7 descendants of its own
- K220826: LED Curing Light (2022), 2 descendants of its own
- K221152: CuringPen Dental Curing Light (2022), 1 descendant of its own

## Indications for use
For the polymerization of light-curing dental materials curing in the wavelength range of 380-515 nm.

Source page: https://510kreport.com/device/K091020
Methodology: https://510kreport.com/methodology