# K152383: Ceramill Zolid FX

- Pathway: 510(k) (Traditional)
- Applicant: Emergo Europe Consulting
- Decided: Sep 21, 2015 after 28 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 K980986 (1998). 6 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063511: Ceramill ZI, Amann Girrbach America, Inc. (2007) Summary page 4.

## Most influential descendants
- K170050: Z-CAD smile (2018), 1 descendant of its own
- K222836: Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs (2023), 0 descendants of its own
- K173971: K2 Zirkon Blank white classic; K2 Zirkon Blank translucent; K2 Blanks extreme translucent (2018), 0 descendants of its own

## Indications for use
“Ceramill Zolid FX" preshade are blanks made of zirconium oxide (ZrO2) for type 11, class 5 dental applications in accordance with DIN EN ISO 6872. They are used for manufacturing permanent and removable prosthetic restorations (e.g., crowns and three-unit bridges to the molar region) using CNC milling machines (e.g., Ceramill Motion).

Source page: https://510kreport.com/device/K152383
Methodology: https://510kreport.com/methodology