# K973221: Composite 168 Restorative System

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Feb 9, 1998 after 166 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 K863092 (1986). 2 ancestors in all.
102 later devices descend from it; 5 cite it directly.
0 of 105 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K863092: Dental Composite Restorative, Dentsply Intl. (1986) Summary page 1.
- K941899: Sdi Composties, Southern Dental Industries, Inc. (1994) Summary page 1.

## Most influential descendants
- 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
- K081850: Bisque Zirconia Blanks, Type Byz (2008), 43 descendants of its own

## Indications for use
COMPOSITE 168 RESTORATIVE SYSTEM is to be used with Prime & Bond™ 2.1 Universal Light Cured Dental Adhesive System: Indicated for cavity Classes I, II, III, IV, V, and VI in anterior and posterior teeth. May be used as a direct restorative material May be used for fabrication of inlays and onlays

Source page: https://510kreport.com/device/K973221
Methodology: https://510kreport.com/methodology