510(k) · Cleared
ClearedObsidian® Press Over Zirconia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prismatik Dentalcraft, Inc. · EIH Powder, Porcelain
Cleared on Jul 30, 2026 as substantially equivalent to K141887 (Prismatik Dentalcraft, Inc., 2014) after a 29-day review. Its family tree reaches back 3 generations to 1998.
- Decided
- Jul 30, 2026
- Review
- 29 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K982616 (1998). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK982616 Ips Empress 2Ivoclar North America, Inc. · 1998
- 2 generations backK100781 Obsidian Ceramic BlocksPrismatik Dentalcraft, Inc. · 2010
- 1 generation backK141887 Obsidian Press (All Ceramic and Pom)Prismatik Dentalcraft, Inc. · 2014
- This deviceK262239 Obsidian® Press Over ZirconiaPrismatik Dentalcraft, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K982616 | Ips Empress 2 | Ivoclar North America, Inc. | 1998 | — |
| −2 | K100781 | Obsidian Ceramic Blocks | Prismatik Dentalcraft, Inc. | 2010 | — |
| −1 | K141887 | Obsidian Press (All Ceramic and Pom) | Prismatik Dentalcraft, Inc. | 2014 | — |
| 0 (this device) | K262239 | Obsidian® Press Over Zirconia | Prismatik Dentalcraft, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2012 | 2 | 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 |
|---|---|---|---|
| * | K141887 | Obsidian Press (All Ceramic and Pom)Summary page 5…er for clinical use Regulation Number: 872.6660 Regulatory Class: Class II Product Code: EIH LEGALLY MARKETED PREDICATE DEVICE (21 CFR 807.92(a)(3)) Predicate 510(k) #: K141887 (Primary Predicate) Predicate Device Trade Name: Obsidian® Press (All-Ceramic and POM) Product Code: EIH DEVICE DESCRIPTION SUMMA… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 2 companies; a new generation was cleared every 11.7 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 1 other device also cites its predicate K141887.
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
Obsidian® Press Over Zirconia is used to fabricate press over zirconia dental prostheses in the nature of crowns and bridges for anterior and posterior applications.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K262239 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262239: Obsidian® Press Over Zirconia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262239
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026