# K160102: Amber Mill Series and Amber Press Series

- Pathway: 510(k) (Traditional)
- Applicant: Hass Corp.
- Decided: Jul 14, 2016 after 177 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). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 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 4.
- K141887: Obsidian Press (All Ceramic and Pom), Prismatik Dentalcraft, Inc. (2014) Summary page 4.

## Indications for use
Amber Mill Series are indicated for fabricating glass ceramic restorations such as single-unit anterior and posterior crowns, veneers, inlays/onlays, and anterior 3-unit bridges using CAD/CAM System. Amber Press Series are indicated for fabricating glass ceramic restorations such as single-unit anterior and posterior crowns, veneers, inlays/onlays, and anterior 3-unit bridges using hot press technique.

Source page: https://510kreport.com/device/K160102
Methodology: https://510kreport.com/methodology