# K100781: Obsidian Ceramic Blocks

- Pathway: 510(k) (Abbreviated)
- Applicant: Prismatik Dentalcraft, Inc.
- Decided: Jun 21, 2010 after 94 days
- Product code: EIH (Powder, Porcelain)
- Device class: 2
- Regulation: 21 CFR 872.6660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K982616 (1998). 2 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051705: Ips E.Max Cad/Ips E.Max Zircad, Ivoclar Vivadent, Inc. (2005) Summary page 1.
- K982616: Ips Empress 2, Ivoclar North America, Inc. (1998) Summary page 1.

## Most influential descendants
- K141887: Obsidian Press (All Ceramic and Pom) (2014), 2 descendants of its own
- K141788: Obsidian Milling Blocks (2014), 2 descendants of its own
- K262239: Obsidian® Press Over Zirconia (2026), 0 descendants of its own
- K234014: Obsidian® NOW (2024), 0 descendants of its own
- K160102: Amber Mill Series and Amber Press Series (2016), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K100781
Methodology: https://510kreport.com/methodology