# K173971: K2 Zirkon Blank white classic; K2 Zirkon Blank translucent; K2 Blanks extreme translucent

- Pathway: 510(k) (Traditional)
- Applicant: Yeti Dentalprodukte GmbH
- Decided: Nov 15, 2018 after 321 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). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072569: Metoxit Cam-Blanks, Metoxit AG (2007) Summary page 4.
- K063511: Ceramill ZI, Amann Girrbach America, Inc. (2007) Summary page 4.
- K152383: Ceramill Zolid FX, Emergo Europe Consulting (2015) Summary page 4.

## Indications for use
Zircon Blanks are used for milling using digital STL-files to produce Crowns, Bridges and monolithic works. We propose the K2 Zircon Blanks for anterior and posterior restorations. Table 1: Indication of use and maximum intermediate elements Single crown: Anterior and Posterior. Bridges: Anterior and Posterior. K2 Zircon Blank white classic: single crowns—anterior and posterior; bridges—2 anterior, 2 posterior. K2 Zircon Blank translucent: single crowns—anterior and posterior; bridges—2 anterior, 2 posterior. K2 Zircon Blank extreme translucent: single crowns—anterior and posterior; bridges—1 anterior, none posterior. All K2 Zircon Blanks are indicated to be colored with Dip & Brush K2 CAD CAM Zircon Liquids. K2 Zircon Blanks should be not used by the General public or over-the-counter.

Source page: https://510kreport.com/device/K173971
Methodology: https://510kreport.com/methodology