# K990756: Flow Line

- Pathway: 510(k) (Traditional)
- Applicant: Heraeus Kulzer, Inc.
- Decided: May 7, 1999 after 60 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K994304: Arabesk Flow (2000), 0 descendants of its own

## Indications for use
This material is intended for extended pit and fissure sealing; class V restoration, minimal invasive restorations of class I, Il and III; slight form and shade corrections of enamel; splinting of tecth after traumatic impact; adjustments of congenital tooth defects (e.g. enamel hypoplasis); cavity lining in class I and II restorations.

Source page: https://510kreport.com/device/K990756
Methodology: https://510kreport.com/methodology