510(k) · Cleared
ClearedIps E.Max Press Multi
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ivoclar Vivadent, AG · EIH Powder, Porcelain
Cleared on Jun 25, 2012 after a 160-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 9 later devices descend from it.
- Decided
- Jun 25, 2012
- Review
- 160 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 5 citing it directly.
- This deviceK120134 Ips E.Max Press MultiIvoclar Vivadent, AG · 2012
- Descendant · cites it directly · 2 of its ownK161269 CELTRA PressDentsply Sirona · 2016
- Descendant · cites it directly · 2 of its ownK141887 Obsidian Press (All Ceramic and Pom)Prismatik Dentalcraft, Inc. · 2014
- Descendant · 2 generations on · 1 of its ownK162888 CerconDentsply Sirona · 2017
- Descendant · 2 generations on · 0 of its ownK262239 Obsidian® Press Over ZirconiaPrismatik Dentalcraft, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK241557 Cercon® yo MLDentsply Sirona · 2024
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K161269CELTRA PressDentsply Sirona · 2016 · cites it directly2descendants
- K141887Obsidian Press (All Ceramic and Pom)Prismatik Dentalcraft, Inc. · 2014 · cites it directly2descendants
- K162888CerconDentsply Sirona · 2017 · 2 generations on1descendant
- K262239Obsidian® Press Over ZirconiaPrismatik Dentalcraft, Inc. · 2026 · 2 generations on0descendants
- K241557Cercon® yo MLDentsply Sirona · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K120134 | Ips E.Max Press Multi | Ivoclar Vivadent, AG | 2012 | — |
| +1 | K161269 | CELTRA Press | Dentsply Sirona | 2016 | — |
| +1 | K141887 | Obsidian Press (All Ceramic and Pom) | Prismatik Dentalcraft, Inc. | 2014 | — |
| +2 | K162888 | Cercon | Dentsply Sirona | 2017 | — |
| +2 | K262239 | Obsidian® Press Over Zirconia | Prismatik Dentalcraft, Inc. | 2026 | — |
| +2 | K241557 | Cercon® yo ML | Dentsply Sirona | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (9)
5 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?
- Of its descendants, K161269 (Dentsply Sirona, 2016) has gone furthest, with 2 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. 2012, 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?
IPS e.max Press and IPS emax Press Multi is an all-ceramic system for the creation of
Occlusal veneers
Thin Veneers
Veneers
Inlays
Onlays
Crowns in the anterior and posterior region
3-unit bridges in the anterior region
3-unit bridges in the premolar region up to the second premolar as the termiinal abutment
Crown, splinted crown or 3 unit bridge up to the second premolar placed on top of an implant abutment.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K120134 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120134: Ips E.Max Press Multi.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120134
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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