# K042929: Estenia C&B

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Medical Kurashiki Plant
- Decided: Dec 6, 2004 after 45 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: 7 generations back to K931812 (1993). 43 ancestors in all.
12 later devices descend from it; 3 cite it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012707: Estenia, Kuraray Medical, Inc. (2001)
- K033267: Epricord, Kuraray Medical, Inc. (2003) Summary page 1.
- K012737: Chroma Zone Color Stain, Kuraray Medical, Inc. (2001) Summary page 1.
- K992645: Sinfony, Espe Dental AG (1999) Summary page 1.
- K962878: Targis System, Ivoclar North America, Inc. (1996) Summary page 1.
- K954115: Artglass & Kevloc, Heraeus Kulzer, Inc. (1995) Summary page 1.
- K972292: Solidex, Shofu Dental Corp. (1997) Summary page 1.
- K020131: Venus Universal Light Curing Composite, Heraeus Kulzer, Inc. (2002) Summary page 1.
- K964578: Fibrekor, Jeneric/Pentron, Inc. (1996)
- K012442: Modification to Clearfil SE Bond, Kuraray Medical, Inc. (2001) Summary page 1.
- K954689: Connect, Sybron Dental Specialties, Inc. (1995) Summary page 1.

## Most influential descendants
- 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
- K150704: PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit (Universal (A2)), Introductory Kit (Clear), Sample Pack (Universal (A2)), Paste (Universal (A2)), Paste (Clear), Paste (Brown (A4)), Paste (White), Paste (Opaque), Try-in Paste (Universal (A2)), Try-in Paste (Clear), Try-in Paste (Brown (A4)), Try-in Paste (White), Try-in Paste (Opaque), Tooth Primer (2015), 2 descendants of its own
- K071169: Clearfil Majesty Posterior PLT (2007), 1 descendant of its own

## Indications for use
ESTENIA C&B is indicated for the following applications for the restoring crowns and defects. 1) Facing cast crowns and facing cast bridges 2) Jacket crowns 3) Inlays and onlays 4) Bridges with frameworks

Source page: https://510kreport.com/device/K042929
Methodology: https://510kreport.com/methodology