# K984201: Denzir

- Pathway: 510(k) (Traditional)
- Applicant: Dentronic AB
- Decided: Sep 29, 1999 after 309 days
- Product code: EIH (Powder, Porcelain)
- Device class: 2
- Regulation: 21 CFR 872.6660
- 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 K830955 (1983). 6 ancestors in all.
93 later devices descend from it; 8 cite it directly.
0 of 100 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973221: Composite 168 Restorative System, Dentsply Intl. (1998) Summary page 1.
- K971869: Finesse All-Ceramic System, Dentsply Intl. (1997) Summary page 1.
- K943168: Clearfil AP-X, Kuraray Company, Ltd. (1994) Summary page 1.

## Most influential descendants
- 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
- K093560: Upcera Zirconia Blanks (2010), 41 descendants of its own

## Indications for use
Intended to restore carious lesions or structural defects in teeth. It is intended for use in cavities Classes I, II, and V (inlays and onlays) and as a restorative material intended for veneers, crowns and bridges.

Source page: https://510kreport.com/device/K984201
Methodology: https://510kreport.com/methodology