# K141887: Obsidian Press (All Ceramic and Pom)

- Pathway: 510(k) (Traditional)
- Applicant: Prismatik Dentalcraft, Inc.
- Decided: Nov 6, 2014 after 115 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). 5 ancestors in all.
2 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)
- K100781: Obsidian Ceramic Blocks, Prismatik Dentalcraft, Inc. (2010) Summary page 5.
- K120134: Ips E.Max Press Multi, Ivoclar Vivadent, AG (2012) Summary page 5.
- K121359: Ips 99 One and Ips 99 Ceram, Ivoclar Vivadent, AG (2012) Summary page 5.

## Most influential descendants
- K262239: Obsidian® Press Over Zirconia (2026), 0 descendants of its own
- K160102: Amber Mill Series and Amber Press Series (2016), 0 descendants of its own

## Indications for use
The Obsidian™ Press ceramic is used to fabricate Press Over Metal dental prostheses in the nature of crowns and bridges as well as monolithic dental prostheses in the nature of crowns, partial crowns, veneers, inlays, and onlays for posterior and anterior applications, as well as 3-unit anterior bridges (including pre-molar region as terminal abutment) using pressing methods.

Source page: https://510kreport.com/device/K141887
Methodology: https://510kreport.com/methodology