# K982164: Estenia

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray America, Inc.
- Decided: Aug 10, 1998 after 52 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 K932154 (1993). 7 ancestors in all.
18 later devices descend from it; 1 cites 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)
- K962878: Targis System, Ivoclar North America, Inc. (1996) Summary page 1.
- K955331: Belleglashp, Sybron Dental Specialties, Inc. (1996) Summary page 1.
- K954115: Artglass & Kevloc, Heraeus Kulzer, Inc. (1995) Summary page 1.
- K972292: Solidex, Shofu Dental Corp. (1997) Summary page 1.
- K964578: Fibrekor, Jeneric/Pentron, Inc. (1996) Summary page 1.
- K940800: Dentacolor Vita (VS) Shade System, Heraeus Kulzer, Inc. (1994) Summary page 1.
- K932154: Conquest Crystal, Jeneric/Pentron, Inc. (1993) Summary page 1.

## Most influential descendants
- K012707: Estenia (2001), 17 descendants of its own
- 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

## Indications for use
1) Jacket crown 2) Facing crown 3) Inlay and onlay

Source page: https://510kreport.com/device/K982164
Methodology: https://510kreport.com/methodology