# K973235: Dyract AP Restorative

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Feb 5, 1998 after 161 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: 1 generation back to K950991 (1995). 1 ancestor in all.
10 later devices descend from it; 5 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950991: Dyract II Restorative, Dentsply Intl. (1995) Summary page 1.

## Most influential descendants
- 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
- K050880: Dyract Extra Restorative (2005), 0 descendants of its own

## Indications for use
Used as a permanent restorative material in all cavity classes for both permanent and deciduous teeth; as a base material underneath amalgams, ceramics, cast metal restorations, and composites; as a laminate or open sandwich technique; for root caries lesions; and for core build-up

Source page: https://510kreport.com/device/K973235
Methodology: https://510kreport.com/methodology