# K950991: Dyract II Restorative

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Mar 23, 1995 after 20 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.
12 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K973235: Dyract AP Restorative (1998), 10 descendants of its own
- K982395: Dytract Flow Restorative (1998), 3 descendants of its own
- K040144: Quixx Posterior Restorative (2004), 2 descendants of its own
- K994056: Admira (2000), 1 descendant of its own
- K053391: X-Tra Fil (2006), 0 descendants of its own

Source page: https://510kreport.com/device/K950991
Methodology: https://510kreport.com/methodology