510(k) · Cleared
ClearedObsidian Milling Blocks
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 Aug 20, 2014 as substantially equivalent to K100781 (Prismatik Dentalcraft, Inc., 2010) after a 49-day review. Its family tree reaches back 2 generations to 1998. 2 later devices descend from it.
- Decided
- Aug 20, 2014
- Review
- 49 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K982616 (1998). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK982616 Ips Empress 2Ivoclar North America, Inc. · 1998
- 1 generation backK100781 Obsidian Ceramic BlocksPrismatik Dentalcraft, Inc. · 2010
- This deviceK141788 Obsidian Milling BlocksPrismatik Dentalcraft, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK234014 Obsidian® NOWPrismatik Dentalcraft, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK160102 Amber Mill Series and Amber Press SeriesHass Corp. · 2016
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K982616 | Ips Empress 2 | Ivoclar North America, Inc. | 1998 | — |
| −1 | K100781 | Obsidian Ceramic Blocks | Prismatik Dentalcraft, Inc. | 2010 | — |
| 0 (this device) | K141788 | Obsidian Milling Blocks | Prismatik Dentalcraft, Inc. | 2014 | — |
| +1 | K234014 | Obsidian® NOW | Prismatik Dentalcraft, Inc. | 2024 | — |
| +1 | K160102 | Amber Mill Series and Amber Press Series | Hass Corp. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2024 | 1 | 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 |
|---|---|---|---|
| * | K100781 | Obsidian Ceramic BlocksSummary page 4…1, 2014 Obsidian" Milling Blocks 21 CFR 872.6660 Porcelain powder for clinical use Class II, EIH Dental IDENTIFICATION OF PREDICATE DEVICE Obsidian" Ceramic Blocks-K100781 Page 25 of 192 Page 11 of 32 1 | PRISMATIK 4 DENTALCRAFT, INC. D. PROPOSED DEVICE DESCRIPTION The Obsidian™ M… | 2010 |
What descends from it? (2)
2 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?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 11.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K234014 (Prismatik Dentalcraft, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K100781.
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
The Obsidian™ Milling Blocks is used to fabricate ceramic dental prostheses in the nature of crowns and bridges for
posterior and anterior applications using CAD/CAM methods.
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/K141788 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141788: Obsidian Milling Blocks.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141788
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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