# K971869: Finesse All-Ceramic System

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Sep 11, 1997 after 113 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: 1 generation back to K830955 (1983). 1 ancestor in all.
100 later devices descend from it; 4 cite it directly.
0 of 102 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K830955: Dental Ceramic for Fabrication of Crown, Dentsply Intl. (1983) 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
Used only with FINESSE™ Low-Fusing Porcelain for the fabrication of dental restorations: for inlays, onlays, veneers, complete crowns on anterior teeth, and for single crowns on selected posterior teeth.

Source page: https://510kreport.com/device/K971869
Methodology: https://510kreport.com/methodology