# K863092: Dental Composite Restorative

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Sep 19, 1986 after 37 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.
108 later devices descend from it; 2 cite it directly.
0 of 109 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
- K973221: Composite 168 Restorative System (1998), 102 descendants of its own
- K984201: Denzir (1999), 93 descendants of its own
- K023327: Cynovad Zirkon (2002), 91 descendants of its own
- K043472: Medin Tech Zirconia-CP10, SS1000 (2005), 80 descendants of its own
- K062695: Sagemax Z-Blank (2006), 76 descendants of its own

Source page: https://510kreport.com/device/K863092
Methodology: https://510kreport.com/methodology