510(k) · Cleared
ClearedObsidian Ceramic 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 Jun 21, 2010 as substantially equivalent to K051705 (Ivoclar Vivadent, Inc., 2005) and 1 other predicate after a 94-day review. Its family tree reaches back 1 generation to 1998. 5 later devices descend from it.
- Decided
- Jun 21, 2010
- Review
- 94 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K982616 (1998). 2 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK982616 Ips Empress 2Ivoclar North America, Inc. · 1998
- This deviceK100781 Obsidian Ceramic BlocksPrismatik Dentalcraft, Inc. · 2010
- Descendant · cites it directly · 2 of its ownK141887 Obsidian Press (All Ceramic and Pom)Prismatik Dentalcraft, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK141788 Obsidian Milling BlocksPrismatik 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 ownK234014 Obsidian® NOWPrismatik Dentalcraft, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK160102 Amber Mill Series and Amber Press SeriesHass Corp. · 2016
Most influential descendants
Showing 5 of 5 · See all- K141887Obsidian Press (All Ceramic and Pom)Prismatik Dentalcraft, Inc. · 2014 · cites it directly2descendants
- K141788Obsidian Milling BlocksPrismatik Dentalcraft, Inc. · 2014 · cites it directly2descendants
- K262239Obsidian® Press Over ZirconiaPrismatik Dentalcraft, Inc. · 2026 · 2 generations on0descendants
- K234014Obsidian® NOWPrismatik Dentalcraft, Inc. · 2024 · 2 generations on0descendants
- K160102Amber Mill Series and Amber Press SeriesHass Corp. · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K982616 | Ips Empress 2 | Ivoclar North America, Inc. | 1998 | — |
| 0 (this device) | K100781 | Obsidian Ceramic Blocks | Prismatik Dentalcraft, Inc. | 2010 | — |
| +1 | K141887 | Obsidian Press (All Ceramic and Pom) | Prismatik Dentalcraft, Inc. | 2014 | — |
| +1 | K141788 | Obsidian Milling Blocks | Prismatik Dentalcraft, Inc. | 2014 | — |
| +2 | K262239 | Obsidian® Press Over Zirconia | Prismatik Dentalcraft, Inc. | 2026 | — |
| +2 | K234014 | Obsidian® NOW | Prismatik Dentalcraft, Inc. | 2024 | — |
| +2 | 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 |
|---|---|---|
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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? (2)
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 |
|---|---|---|---|
| * | K051705 | Ips E.Max Cad/Ips E.Max ZircadSummary page 1…y equivalent to other legally marketed devices in the United States. Substantially equivalent devices include the following: (1) IPS e.max CAD/IPS e.max ZirCAD (Ivoclar, K051705); and (2), IPS Empress 2 (Ivoclar, K982616). Description of the Device: The device is comprised of dental porcelain powder in th… | 2005 |
| * | K982616 | Ips Empress 2Summary page 1…ces in the United States. Substantially equivalent devices include the following: (1) IPS e.max CAD/IPS e.max ZirCAD (Ivoclar, K051705); and (2), IPS Empress 2 (Ivoclar, K982616). Description of the Device: The device is comprised of dental porcelain powder in the nature of a lithium silicate glass cerami… | 1998 |
What descends from it? (5)
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?
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 device is used to fabricate ceramic dental prostheses in the nature of crowns and bridges for posterior and anterior applications using CAD/CAM or hot-press methods.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100781 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100781: Obsidian Ceramic Blocks.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100781
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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