# K170050: Z-CAD smile

- Pathway: 510(k) (Traditional)
- Applicant: Metoxit AG
- Decided: Aug 23, 2018 after 595 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: 4 generations back to K980986 (1998). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152383: Ceramill Zolid FX, Emergo Europe Consulting (2015) Summary page 4.

## Most influential descendants
- K222836: Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs (2023), 0 descendants of its own

## Indications for use
METOXIT Z-CAD® smile blanks are indicated for the preparation of full ceramic crowns, inlays, onlays, veneers and 3 unit bridges in the anterior area. All white Z-CAD® smile blanks are indicated to be coloured with Z-CAD® Liquid smile-TC. The Z-CAD® Liquid smile-TC will be used to dye white pre-sintered zirconia restorations milled from Z-CAD® smile blanks in the dental field.

Source page: https://510kreport.com/device/K170050
Methodology: https://510kreport.com/methodology