510(k) · Cleared
ClearedIps 99 One and Ips 99 Ceram
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 Jul 27, 2012 after an 81-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Jul 27, 2012
- Review
- 81 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK121359 Ips 99 One and Ips 99 CeramIvoclar Vivadent, AG · 2012
- Descendant · cites it directly · 2 of its ownK141887 Obsidian Press (All Ceramic and Pom)Prismatik Dentalcraft, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK262239 Obsidian® Press Over ZirconiaPrismatik Dentalcraft, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK160102 Amber Mill Series and Amber Press SeriesHass Corp. · 2016
- Descendant · cites it directly · 0 of its ownK152103 IPS Style Ceram, IPS Style Ceram One, IPS Style PressIvoclar Vivadent, AG · 2016
- Descendant · cites it directly · 0 of its ownK151894 IPS IvocolorIvoclar Vivadent, AG · 2015
Most influential descendants
Showing 5 of 5 · See all- K141887Obsidian Press (All Ceramic and Pom)Prismatik Dentalcraft, Inc. · 2014 · cites it directly2descendants
- K262239Obsidian® Press Over ZirconiaPrismatik Dentalcraft, Inc. · 2026 · 2 generations on0descendants
- K160102Amber Mill Series and Amber Press SeriesHass Corp. · 2016 · 2 generations on0descendants
- K152103IPS Style Ceram, IPS Style Ceram One, IPS Style PressIvoclar Vivadent, AG · 2016 · cites it directly0descendants
- K151894IPS IvocolorIvoclar Vivadent, AG · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K121359 | Ips 99 One and Ips 99 Ceram | Ivoclar Vivadent, AG | 2012 | — |
| +1 | K141887 | Obsidian Press (All Ceramic and Pom) | Prismatik Dentalcraft, Inc. | 2014 | — |
| +2 | K262239 | Obsidian® Press Over Zirconia | Prismatik Dentalcraft, Inc. | 2026 | — |
| +2 | K160102 | Amber Mill Series and Amber Press Series | Hass Corp. | 2016 | — |
| +1 | K152103 | IPS Style Ceram, IPS Style Ceram One, IPS Style Press | Ivoclar Vivadent, AG | 2016 | — |
| +1 | K151894 | IPS Ivocolor | Ivoclar Vivadent, AG | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 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? (5)
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?
- Of its descendants, K141887 (Prismatik Dentalcraft, Inc., 2014) 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 89 One is a one-layer venaering ceramic for the fabrication of metal-ceramic restorations using the most popular dental alloys in the CTE range of 13.8-15.0 x 109K (26-500°C)
IPS €8 Ceram Is a conventicnal muli-layer veneering ceramic for the fabrication of metal-&eggflc restorations using the most popular dental alloys in the CTE range of 13.8-15.0 x 10%K 00°C).
IPS 89 Is Intended to be used for inlays, onlays, veneers, and anterior/posterior PFM crowns.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K121359 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121359: Ips 99 One and Ips 99 Ceram.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121359
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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