# K161922: XP202

- Pathway: 510(k) (Traditional)
- Applicant: 3M Deutschland GmbH
- Decided: Sep 1, 2016 after 50 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: 3 generations back to K011394 (2001). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143439: KATANA Zirconia, Kuraray Noritake Dental, Inc. (2015) Summary page 4.
- K011394: Lava Frame, Lava Frame Shade, Lava Ceram, Espe Dental AG (2001) Summary page 4.
- K120011: Heisenberg Effect Shades, 3M Espe AG (2012) Summary page 4.

## Most influential descendants
- K233158: Copra Smile, Copra Supreme Hyperion (2024), 0 descendants of its own

## Indications for use
Single crowns Bridges with a maximum of one pontic between two crowns Inlays, onlays, and veneers

Source page: https://510kreport.com/device/K161922
Methodology: https://510kreport.com/methodology