# K234014: Obsidian® NOW

- Pathway: 510(k) (Traditional)
- Applicant: Prismatik Dentalcraft, Inc.
- Decided: Feb 27, 2024 after 70 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: 3 generations back to K982616 (1998). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141788: Obsidian Milling Blocks, Prismatik Dentalcraft, Inc. (2014) Summary page 5.

## Indications for use
Obsidian® NOW is used to fabricate ceramic dental prosthesis in the nature of crowns for posterior and anterior applications using CAD/CAM technology. The block is processed through dental laboratories or by dental professionals.

Source page: https://510kreport.com/device/K234014
Methodology: https://510kreport.com/methodology