510(k) · Cleared
ClearedPrettau, ICE, Z-White zirconia blanks
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zirkonzahn Srl · EIH Powder, Porcelain
Cleared on Apr 4, 2019 as substantially equivalent to K180703 (Vita Zahnfabrik H.Rauter GmbH Co., 2018) after a 127-day review. Its family tree reaches back 2 generations to 2002. 7 later devices descend from it.
- Decided
- Apr 4, 2019
- Review
- 127 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K022996 (2002). 7 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK022996 Vita in-Ceram YZ Cubes for CerecVident · 2002
- 1 generation backK180703 VITA YZ ST and VITA YZ XTVita Zahnfabrik H.Rauter GmbH Co. · 2018
- This deviceK183304 Prettau, ICE, Z-White zirconia blanksZirkonzahn Srl · 2019
- Descendant · cites it directly · 3 of its ownK222626 Dental Zirconia CeramicAidite (Qinhuangdao) Technology Co., Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK212765 Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankBloomden Bioceramics (HuNan) Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK260370 Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankBloomden Bioceramics (HuNan) Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK250811 Dental Zirconia CeramicAidite (Qinhuangdao) Technology Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK242458 ArgenZ MTZArgen Corporation · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K222626Dental Zirconia CeramicAidite (Qinhuangdao) Technology Co., Ltd. · 2022 · cites it directly3descendants
- K212765Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankBloomden Bioceramics (HuNan) Co., Ltd. · 2021 · cites it directly1descendant
- K260370Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankBloomden Bioceramics (HuNan) Co., Ltd. · 2026 · 2 generations on0descendants
- K250811Dental Zirconia CeramicAidite (Qinhuangdao) Technology Co., Ltd. · 2025 · 2 generations on0descendants
- K242458ArgenZ MTZArgen Corporation · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K022996 | Vita in-Ceram YZ Cubes for Cerec | Vident | 2002 | — |
| −1 | K180703 | VITA YZ ST and VITA YZ XT | Vita Zahnfabrik H.Rauter GmbH Co. | 2018 | — |
| 0 (this device) | K183304 | Prettau, ICE, Z-White zirconia blanks | Zirkonzahn Srl | 2019 | — |
| +1 | K222626 | Dental Zirconia Ceramic | Aidite (Qinhuangdao) Technology Co., Ltd. | 2022 | — |
| +1 | K212765 | Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Bloomden Bioceramics (HuNan) Co., Ltd. | 2021 | — |
| +2 | K260370 | Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Bloomden Bioceramics (HuNan) Co., Ltd. | 2026 | — |
| +2 | K250811 | Dental Zirconia Ceramic | Aidite (Qinhuangdao) Technology Co., Ltd. | 2025 | — |
| +2 | K242458 | ArgenZ MTZ | Argen Corporation | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EIH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EIH device
- #1 K192231 Dental Glass Ceramics Blocksscore 15.2 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K180703 | VITA YZ ST and VITA YZ XTSummary page 5…ED PREDICATE DEVICE Company: VITA Zahnfabrik H. Rauter GmbH Co. Device Name: VITA YZ ST and VITA YZ XT Product Code: EIH 510(k) Number: K180703 INDICATIONS FOR USE Prettau®, Prettau® 2, Prettau® 2 Coloured, Prettau® 2 Dispersive, ICE Translucent, ICE Premium, ICE A… | 2018 |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 15.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K222626 (Aidite (Qinhuangdao) Technology Co., Ltd., 2022) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K180703.
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · EIH
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EIH
84in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EIH
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EIH
1in 2025
MAUDE reports naming product code EIH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 15 | 63 | 0 | 0 |
| 2008 | 15 | 87 | 0 | 1 |
| 2009 | 15 | 79 | 0 | 0 |
| 2010 | 14 | 89 | 0 | 0 |
| 2011 | 14 | 80 | 0 | 1 |
| 2012 | 9 | 96 | 0 | 0 |
| 2013 | 16 | 107 | 0 | 6 |
| 2014 | 18 | 118 | 0 | 1 |
| 2015 | 23 | 118 | 0 | 0 |
| 2016 | 22 | 187 | 21 | 4 |
| 2017 | 16 | 149 | 0 | 1 |
| 2018 | 10 | 139 | 0 | 2 |
| 2019 | 16 | 125 | 0 | 1 |
| 2020 | 13 | 155 | 0 | 0 |
| 2021 | 17 | 131 | 0 | 22 |
| 2022 | 16 | 89 | 0 | 0 |
| 2023 | 15 | 114 | 0 | 0 |
| 2024 | 28 | 89 | 0 | 7 |
| 2025 | 13 | 84 | 1 | 1 |
| 2026 | 14 | 73 | 0 | — |
What is it indicated for?
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…
Read the full statement (207 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183304 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183304: Prettau, ICE, Z-White zirconia blanks.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183304
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026