510(k) · Cleared
ClearedPressx ZR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wieland Dental + Technik GmbH & Co. KG · EIH Powder, Porcelain
Cleared on Apr 30, 2007 after a 40-day review. The FDA summary names no predicate by number. 10 later devices descend from it.
- Decided
- Apr 30, 2007
- Review
- 40 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 1 citing it directly.
- This deviceK070772 Pressx ZRWieland Dental + Technik GmbH & Co. KG · 2007
- Descendant · cites it directly · 9 of its ownK123952 Cerec Blocs C inSirona Dental Systems GmbH · 2013
- Descendant · 2 generations on · 8 of its ownK141727 Dental Lithium Disilicate Glass Ceramic Block (UP. Press Series and…Liaoning Upcera Co., Ltd. · 2014
- Descendant · 3 generations on · 5 of its ownK192231 Dental Glass Ceramics BlocksAidite (Qinhuangdao) Technology Co., Ltd. · 2020
- Descendant · 4 generations on · 0 of its ownK242407 Dental Glass Ceramics Blocks (HT, LT, MT)Hunan Vsmile Biotechnology Co., Ltd. · 2024
- Descendant · 4 generations on · 0 of its ownK241715 Dental Glass Ceramics Blocks (HT,LT,ST)Aidite (Qinhuangdao) Technology Co., Ltd. · 2024
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K123952Cerec Blocs C inSirona Dental Systems GmbH · 2013 · cites it directly9descendants
- K141727Dental Lithium Disilicate Glass Ceramic Block (UP. Press Series and UP. Cad Series)Liaoning Upcera Co., Ltd. · 2014 · 2 generations on8descendants
- K192231Dental Glass Ceramics BlocksAidite (Qinhuangdao) Technology Co., Ltd. · 2020 · 3 generations on5descendants
- K242407Dental Glass Ceramics Blocks (HT, LT, MT)Hunan Vsmile Biotechnology Co., Ltd. · 2024 · 4 generations on0descendants
- K241715Dental Glass Ceramics Blocks (HT,LT,ST)Aidite (Qinhuangdao) Technology Co., Ltd. · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K070772 | Pressx ZR | Wieland Dental + Technik GmbH & Co. KG | 2007 | — |
| +1 | K123952 | Cerec Blocs C in | Sirona Dental Systems GmbH | 2013 | — |
| +2 | K141727 | Dental Lithium Disilicate Glass Ceramic Block (UP. Press Series and UP. Cad… | Liaoning Upcera Co., Ltd. | 2014 | — |
| +3 | K192231 | Dental Glass Ceramics Blocks | Aidite (Qinhuangdao) Technology Co., Ltd. | 2020 | — |
| +4 | K242407 | Dental Glass Ceramics Blocks (HT, LT, MT) | Hunan Vsmile Biotechnology Co., Ltd. | 2024 | — |
| +4 | K241715 | Dental Glass Ceramics Blocks (HT,LT,ST) | Aidite (Qinhuangdao) Technology Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 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?
The FDA summary names no predicate by number.
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123952 | Cerec Blocs C in | 2013 | 9 |
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?
- Of its descendants, K123952 (Sirona Dental Systems GmbH, 2013) has gone furthest, with 9 descendants of its own.
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
PressX Zr is a pressable dental ceramic that can be used by dental technicians to
fabricate all-ceramic restorations by pressing-over zirconium dioxide frameworks.
The indications of these all-ceramic restorations are defined by the manufacturers
of the zirconium dioxide (ZrO2) framework material, and normally encompass
dental crowns and bridges.
The coefficient of thermal expansion [CTE (25 - 500°C)] of these zirconium dioxide
(ZrO 2) frameworks has to equal approximately 10x 10' 61C
1
In addition, PressX Zr can be used to manufacture all-ceramic inlays, onlays, and
veneers without zirconium dioxide frameworks.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070772 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070772: Pressx ZR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070772
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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