# K152103: IPS Style Ceram, IPS Style Ceram One, IPS Style Press

- Pathway: 510(k) (Traditional)
- Applicant: Ivoclar Vivadent, AG
- Decided: May 20, 2016 after 296 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 K940252 (1994). 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)
- K121359: Ips 99 One and Ips 99 Ceram, Ivoclar Vivadent, AG (2012) Summary page 4.
- K071848: Ips Inline Pom System, Ivoclar Vivadent, Inc. (2007) Summary page 4.

## Indications for use
Intended Use: 1PS Style Press — Pressing on metal frameworks and superstructures for the fabrication of full-contour crowns and bridges (staining technique) — Pressing on metal frameworks and superstructures for the fabrication of partially anatomic crowns and bridges (cut-back technique) ~ Pressing of ceramic margins (metal-ceramic) - Pressing of gingiva components (metal-ceramic) - Processing on the most popular dental alloys in the CTE range of 13.8 — 14.5 10-6/K (25 - 500°C) (Cu< 1%, Ag < 10%) - Veneering with the layering materials of IPS Style in the conventional layering technique — Characterization with IPS Ivocolor Shade and Essence stains — Glazing with IPS Ivocolor Glaze Intended Use: IPS Style Ceram and IPS Style Ceram Onc — Conventional multi-layer veneering ceramic for the most popular dental alloys (including electroplating) in the CTE range of 13.8 — 15.2 x 10-6/K (25 — 500°C) (IPS Style Ceram) — One-layer veneering ceramic for the most popular dental alloys (including electroplating) in the CTE range of 13.8 — 15.2 x 10-6/K (25 ~ 500°C) (IPS Style Ceram One) — Veneers on refractory die material (only IPS Style Ceram) — Characterization and veneering of IPS Style Press restorations — Characterization with IPS Ivocolor Shade and Essence stains - Glazing with IPS Ivocolor Glaze

Source page: https://510kreport.com/device/K152103
Methodology: https://510kreport.com/methodology