# K993566: Promptflow

- Pathway: 510(k) (Traditional)
- Applicant: Espe Dental AG
- Decided: Dec 6, 1999 after 46 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
Longest line of descent: 5 generations back to K900510 (1990). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992966: Reference, Espe Dental AG (1999) Summary page 1.
- K982395: Dytract Flow Restorative, Dentsply Intl. (1998) Summary page 1.

## Indications for use
Flowable composite restorative material for: Minimally-invasive fillings Restorations of type II and V cavities (according to Black) Liner for restorations of type I and II cavities Small restorations of type I and II cavities Deciduous tooth fillings Fissure sealing Extended fissure sealing Tunnel preparation Repair of composite fillings and ceramic veneers Filling of defects and undercuts in crowns, inlays, and onlays Cementing porcelain veneers, crowns, inlays, and onlays Refacing acrylic temporaries Blockouts

Source page: https://510kreport.com/device/K993566
Methodology: https://510kreport.com/methodology