# K111257: Heisenberg Dyeing Liquids

- Pathway: 510(k) (Traditional)
- Applicant: 3M Espe AG
- Decided: May 13, 2011 after 9 days
- Product code: EIH (Powder, Porcelain)
- Device class: 2
- Regulation: 21 CFR 872.6660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K011394 (2001). 1 ancestor in all.
6 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011394: Lava Frame, Lava Frame Shade, Lava Ceram, Espe Dental AG (2001) Summary page 1.

## Most influential descendants
- K182833: ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer (2019), 5 descendants of its own
- K190518: Color Liquid, Vita Liquid (2019), 3 descendants of its own
- K220960: BruxZir Opaque Coloring Liquid (2022), 1 descendant of its own
- K231347: BruxZir™ TintEFX Coloring Liquid (2023), 0 descendants of its own
- K230262: BruxZir™ Incisal Coloring Liquid (2023), 0 descendants of its own

## Indications for use
Heisenberg Dyeing Liquids are suited for the shading of Heisenberg zirconia frameworks and Heisenberg all-zirconia, monolithic restorations for anterior and posterior teeth.

Source page: https://510kreport.com/device/K111257
Methodology: https://510kreport.com/methodology