# K142233: zenostar MO, Zenostar T, Zenostar VisualiZr

- Pathway: 510(k) (Traditional)
- Applicant: Wieland Dental + Technik GmbH & Co. KG
- Decided: Jan 5, 2015 after 145 days
- Product code: EIH (Powder, Porcelain)
- Device class: 2
- Regulation: 21 CFR 872.6660
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K011394 (2001). 4 ancestors in all.
1 later device descends 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)
- K051705: Ips E.Max Cad/Ips E.Max Zircad, Ivoclar Vivadent, Inc. (2005) Summary page 4.
- K112710: Zenotec ZR Bridge, Zenostar ZR Translucent, Zenotec Color ZR, Zenostar Color ZR, Wieland Dental + Technik GmbH & Co. KG (2011) Summary page 4.

## Most influential descendants
- K253953: IPS e.max Zirconia (2026), 0 descendants of its own

## Recalls of this device
- Dec 11, 2025 · Class II · Z-2356-2026: Yttrium-stabilized zirconium oxide discs for fixed all-ceramic dental restorations may have reduced or missing dentin layer and when used clinically in the patient's mouth there is an increased risk o

## Indications for use
Zenostar MO and Zenostar T consist of machinable zirconia discs for the preparation of full ceramic crowns, onlays and bridges (anterior and molar). Zenostar VisualiZr is for the temporary dyeing of Zenostar Color Zr solutions according to the Instructions for Use.

Source page: https://510kreport.com/device/K142233
Methodology: https://510kreport.com/methodology