# K982395: Dytract Flow Restorative

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Aug 18, 1998 after 40 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: 2 generations back to K950991 (1995). 3 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973235: Dyract AP Restorative, Dentsply Intl. (1998) Summary page 1.
- K955292: Aeliteflo, Bisco, Inc. (1995) Summary page 1.

## Most influential descendants
- K041272: Dyract Cem Plus Cement (2004), 0 descendants of its own
- K993566: Promptflow (1999), 0 descendants of its own
- K992516: Dyract Seal Compomer Pit & Fissure Sealant (1999), 0 descendants of its own

## Indications for use
Filling of defects and undercuts in crowns, inlays and onlays; Liner under direct restorative materials and under inlay restorations——Class Il box liner; Tunnel preparations; Pit and fissure sealants; Amalgam margin repair; Improving margins of acrylic temporaries; Small class IV repairs; Intraoral porcelain repair; Cementing porcelain veneers, crowns, inlays/onlays; Refacing acrylic temporaries; Blockouts; Covering incisal edge stains; Repair of small enamel defects; Provisional occlusal changes; Class lll, V restorations; Conservative Class | restorations; Margin correction/adjustment of composite crowns for indirect laboratory use

Source page: https://510kreport.com/device/K982395
Methodology: https://510kreport.com/methodology