# K012707: Estenia

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Medical, Inc.
- Decided: Sep 13, 2001 after 30 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: 2 generations back to K932154 (1993). 8 ancestors in all.
17 later devices descend from it; 2 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982164: Estenia, Kuraray America, Inc. (1998) Summary page 1.

## Most influential descendants
- K042929: Estenia C&B (2004), 12 descendants of its own
- K111982: Clearfil DC Core Plus (2011), 6 descendants of its own
- K142625: PANAVIA SA Cement Plus Automix; (Universal (A2), White, Translucent); Value Pack (Universal (A2), Translucent); Automix Trial (Universal (A2), White, Translucent); Mixing tip; Endo tip (SS) (2015), 4 descendants of its own
- K063595: Clearfil Majesty Posterior (2007), 4 descendants of its own
- K023842: Clearfil SE Bond Plus (2003), 3 descendants of its own

## Indications for use
ESTENIA is used for the following cases: 1) Jacket crown 2) Facing crown 3) Inlay and onlay

Source page: https://510kreport.com/device/K012707
Methodology: https://510kreport.com/methodology