# K183304: Prettau, ICE, Z-White zirconia blanks

- Pathway: 510(k) (Traditional)
- Applicant: Zirkonzahn Srl
- Decided: Apr 4, 2019 after 127 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: 2 generations back to K022996 (2002). 2 ancestors in all.
7 later devices descend from it; 3 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)
- K180703: VITA YZ ST and VITA YZ XT, Vita Zahnfabrik H.Rauter GmbH Co. (2018) Summary page 5.

## Most influential descendants
- K222626: Dental Zirconia Ceramic (2022), 3 descendants of its own
- K212765: Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank (2021), 1 descendant of its own
- K260370: Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank (2026), 0 descendants of its own
- K250811: Dental Zirconia Ceramic (2025), 0 descendants of its own
- K242458: ArgenZ MTZ (2024), 0 descendants of its own

## Indications for use
Prettau®, Prettau® 2, Prettau® 2 Coloured, Prettau® 2 Dispersive, ICE Translucent, ICE Premium, ICE Abutment, ICE Translucent Plus, ICE Translucent Plus Coloured, ICE Translucent Plus Dispersive and Z-White are intended for the manufacturing of metal-free partial and single crowns, full arch occlusally screwed bridges, inlays, onlays, and veneers, full contour restorations as well as reduced structures in combination with veneering ceramics. The products are categorized into class 5 according to ISO 6872. Prettau® 3, Prettau® 3 Coloured, Prettau® 3 Dispersive, Prettau® 4 Anterior®, Prettau® 4 Anterior® Coloured and Prettau® 4 Anterior® Dispersive are destined for the manufacturing of metal-free partial and single crowns, max. 3-unit bridges, inlays, onlays and veneers, full contour restorations as well as for reduced structures in combination with veneering ceramics and implant superstructures for 3-unit restorations in the anterior and posterior tooth region. The products have to be categorized as class 4 according to ISO 6872. The products have been developed for use with Colour Liquid, ICE Zirkon Ceramics, ICE Zirkon Stains and ICE Zirkon Stains 3D. Observe the relative instructions of use when using these products. The blocks are suitable for all milling units, which are able to process presintered zirconia and which have the proper clamping device for the corresponding block.

Source page: https://510kreport.com/device/K183304
Methodology: https://510kreport.com/methodology