510(k) · Cleared
ClearedIps Empress 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ivoclar North America, Inc. · EIH Powder, Porcelain
Cleared on Sep 8, 1998 after a 43-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 13 later devices descend from it.
- Decided
- Sep 8, 1998
- Review
- 43 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 4 citing it directly.
- This deviceK982616 Ips Empress 2Ivoclar North America, Inc. · 1998
- Descendant · cites it directly · 5 of its ownK100781 Obsidian Ceramic BlocksPrismatik Dentalcraft, Inc. · 2010
- Descendant · cites it directly · 5 of its ownK994435 Opc 3G All-Ceramic System, Core and Overlay PorcelainsJeneric/Pentron, Inc. · 2000
- Descendant · 2 generations on · 3 of its ownK141400 Dcceram SystemCeramay GmbH & Co.Kg · 2015
- Descendant · 2 generations on · 2 of its ownK141887 Obsidian Press (All Ceramic and Pom)Prismatik Dentalcraft, Inc. · 2014
- Descendant · 2 generations on · 2 of its ownK141788 Obsidian Milling BlocksPrismatik Dentalcraft, Inc. · 2014
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K100781Obsidian Ceramic BlocksPrismatik Dentalcraft, Inc. · 2010 · cites it directly5descendants
- K994435Opc 3G All-Ceramic System, Core and Overlay PorcelainsJeneric/Pentron, Inc. · 2000 · cites it directly5descendants
- K141400Dcceram SystemCeramay GmbH & Co.Kg · 2015 · 2 generations on3descendants
- K141887Obsidian Press (All Ceramic and Pom)Prismatik Dentalcraft, Inc. · 2014 · 2 generations on2descendants
- K141788Obsidian Milling BlocksPrismatik Dentalcraft, Inc. · 2014 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982616 | Ips Empress 2 | Ivoclar North America, Inc. | 1998 | — |
| +1 | K100781 | Obsidian Ceramic Blocks | Prismatik Dentalcraft, Inc. | 2010 | — |
| +1 | K994435 | Opc 3G All-Ceramic System, Core and Overlay Porcelains | Jeneric/Pentron, Inc. | 2000 | — |
| +2 | K141400 | Dcceram System | Ceramay GmbH & Co.Kg | 2015 | — |
| +2 | K141887 | Obsidian Press (All Ceramic and Pom) | Prismatik Dentalcraft, Inc. | 2014 | — |
| +2 | K141788 | Obsidian Milling Blocks | Prismatik Dentalcraft, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (13)
See all 134 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, K100781 (Prismatik Dentalcraft, Inc., 2010) has gone furthest, with 5 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.
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?
Metal free single unit and anterior multiple unit Bonded Crown and Bridge Restoration
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/K982616 · printed Nov 5, 2026
Cite this page
510(k) Report. “K982616: Ips Empress 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982616
Report an extraction error
Are you the manufacturer?
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