# K190272: Bluephase PowerCure

- Pathway: 510(k) (Traditional)
- Applicant: Ivoclar Vivadent, AG
- Decided: Jul 3, 2019 after 145 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
Longest line of descent: 2 generations back to K091020 (2009). 2 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163613: Bluephase Style 20i, Ivoclar Vivadent, AG (2017) Summary page 4.

## Most influential descendants
- 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
- K253131: Curing Light (M-Cure 6) (2026), 0 descendants of its own
- K242386: Bluemoon (2025), 0 descendants of its own

## Indications for use
With its “Polywave” LED with broadband spectrum, Bluephase PowerCure is suitable for the polymerization of all light-curing dental materials curing in the wavelength range of 385 — 515 nm. These materials include restoratives, bonding agents/adhesives, bases, liners, fissure sealants, temporaries, as well as luting materials for brackets and indirect restorations, such as ceramic inlays.

Source page: https://510kreport.com/device/K190272
Methodology: https://510kreport.com/methodology