# K152118: Zenostar MT, Zenostar Color Liquids

- Pathway: 510(k) (Traditional)
- Applicant: Wieland Dental + Technik GmbH & Co. KG
- Decided: Dec 16, 2015 after 139 days
- Product code: EIH (Powder, Porcelain)
- Device class: 2
- Regulation: 21 CFR 872.6660
- Recalls of this device: 21 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K051705 (2005). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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.

## Recalls of this device
- May 27, 2016 · Class II · Z-0017-2017: The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
- May 27, 2016 · Class II · Z-0018-2017: The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
- May 27, 2016 · Class II · Z-0020-2017: The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
- May 27, 2016 · Class II · Z-0021-2017: The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
- May 27, 2016 · Class II · Z-0022-2017: The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
- May 27, 2016 · Class II · Z-0032-2017: The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
- May 27, 2016 · Class II · Z-0019-2017: The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
- May 27, 2016 · Class II · Z-0023-2017: The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
- May 27, 2016 · Class II · Z-0036-2017: The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
- May 27, 2016 · Class II · Z-0027-2017: The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
- May 27, 2016 · Class II · Z-0029-2017: The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
- May 27, 2016 · Class II · Z-0030-2017: The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
- May 27, 2016 · Class II · Z-0031-2017: The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
- May 27, 2016 · Class II · Z-0033-2017: The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
- May 27, 2016 · Class II · Z-0037-2017: The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
- May 27, 2016 · Class II · Z-0024-2017: The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
- May 27, 2016 · Class II · Z-0025-2017: The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
- May 27, 2016 · Class II · Z-0026-2017: The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
- May 27, 2016 · Class II · Z-0028-2017: The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
- May 27, 2016 · Class II · Z-0034-2017: The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
- May 27, 2016 · Class II · Z-0035-2017: The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.

## Indications for use
Zenostar MT (medium translucency) are machinable zirconium oxide discs for the production of all-ceramic crowns, partial crowns and bridges in the anterior and posterior region. Zenostar® MT Color Liquids are ready-made, water-based solutions for shading full contour restorations made from Zenostar MT. They are applied prior to sintering using the brush technique.

Source page: https://510kreport.com/device/K152118
Methodology: https://510kreport.com/methodology