# K153136: Initial LiSi Press

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Jun 30, 2016 after 244 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 K120134 (2012). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120134: Ips E.Max Press Multi, Ivoclar Vivadent, AG (2012) Summary page 4.

## Indications for use
Fabrication of occlusal veneers, thin veneers, veneers, inlays, onlays, crowns in the anterior and posterior region, 3-unit bridges in the anterior region, 3-unit bridges in the premolar region up to the second premolar as the terminal unit, crown or splinted crown on top of an implant abutment and 3-unit bridge up to the second premolar placed on top of an implant abutment.

Source page: https://510kreport.com/device/K153136
Methodology: https://510kreport.com/methodology