# K141788: Obsidian Milling Blocks

- Pathway: 510(k) (Special)
- Applicant: Prismatik Dentalcraft, Inc.
- Decided: Aug 20, 2014 after 49 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: 2 generations back to K982616 (1998). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100781: Obsidian Ceramic Blocks, Prismatik Dentalcraft, Inc. (2010) Summary page 4.

## Most influential descendants
- 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 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.

Source page: https://510kreport.com/device/K141788
Methodology: https://510kreport.com/methodology