# K071848: Ips Inline Pom System

- Pathway: 510(k) (Traditional)
- Applicant: Ivoclar Vivadent, Inc.
- Decided: Aug 30, 2007 after 56 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 K940252 (1994). 2 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041335: PTM System, Dentsply International (2004) Summary page 1.

## Most influential descendants
- K152103: IPS Style Ceram, IPS Style Ceram One, IPS Style Press (2016), 0 descendants of its own
- K123613: Synspar Advanced (2013), 0 descendants of its own
- K090434: Bece Press (2009), 0 descendants of its own

## Indications for use
IPS InLine PoM is a leucite ceramic system for pressing fully anatomical restorations on metal crown and bridge frameworks after the application of opaquer, mainly in the posterior region. Alloy CTE range: 13.8 - 14.5 10-6 K-' 25-500 °C The material is contraindicated for: * Pressing over metal frameworks beyond the CTE range * Very deep sub-gingival preparations * Patients with substantially reduced residual dentition * Patients with bruxism and * Use with alloys with a silver content of more than 10% Other limitations of use: · Combination with any other ceramic materials * Pressing IPS InLine PoM ingots thinner than 0.8mm · Pressing of IPS InLine PoM ingots without a metal framework Layering of IPS InLine Dentin, Incisal, Deep Dentin, Margin, Impulse and Gingiva materials Pressing over metal frameworks that do not exhibit the required minimum thickness for copings or connectors.

Source page: https://510kreport.com/device/K071848
Methodology: https://510kreport.com/methodology