# K120011: Heisenberg Effect Shades

- Pathway: 510(k) (Traditional)
- Applicant: 3M Espe AG
- Decided: Jan 13, 2012 after 10 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: 2 generations back to K011394 (2001). 3 ancestors in all.
2 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)
- K011394: Lava Frame, Lava Frame Shade, Lava Ceram, Espe Dental AG (2001) Summary page 1.
- K112710: Zenotec ZR Bridge, Zenostar ZR Translucent, Zenotec Color ZR, Zenostar Color ZR, Wieland Dental + Technik GmbH & Co. KG (2011) Summary page 2.

## Most influential descendants
- K161922: XP202 (2016), 1 descendant of its own
- K233158: Copra Smile, Copra Supreme Hyperion (2024), 0 descendants of its own

## Indications for use
Heisenberg Effect Shades are suited for more intensive coloring of Heisenberg zirconia frameworks and Heisenberg all-zirconia restorations after basic dyeing using Heisenberg Dyeing Liquids.

Source page: https://510kreport.com/device/K120011
Methodology: https://510kreport.com/methodology