# K103528: Ips Empress Direct Flow

- Pathway: 510(k) (Traditional)
- Applicant: Ivoclar Vivadent, Inc.
- Decided: Feb 25, 2011 after 87 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K122521: Prevent Seal (2013), 1 descendant of its own
- K141717: Pacseal Pit & Fissure Sealant (2015), 0 descendants of its own

## Indications for use
IPS Empress Direct Flow is a light-curing resin-based flowable dental restorative material indicated for, - As an intermediate or covering layer in the fabrication of esthetically demanding composite restorations - Repair of composite restorations (in particular filling of voids, levelling out of porosities and minor chips) - As a thin (< 0.5mm) initial layer under Class I and 11restorations - Small restorations of all types - Extended fissure sealing - Splinting of mobile teeth - Blocking out of undercuts - Repair of composite and ceramic veneers

Source page: https://510kreport.com/device/K103528
Methodology: https://510kreport.com/methodology