# K111982: Clearfil DC Core Plus

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray America, Inc.
- Decided: Nov 17, 2011 after 128 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: 10 generations back to K931812 (1993). 56 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043177: Cleafil DC Core Automix, Kuraray Medical, Inc. (2004) Summary page 1.
- K081583: Clearfil SA Cement, Kuraray Medical, Inc. (2008)
- K062410: Clearfil Esthetic Cement & DC Bond, Kuraray Medical, Inc. (2006) Summary page 1.
- K063593: Clearfil Majesty Flow, Kuraray America, Inc. (2007) Summary page 1.
- K012740: Clearfil AP-X, Kuraray Medical, Inc. (2001) Summary page 1.
- K042929: Estenia C&B, Kuraray Medical Kurashiki Plant (2004) Summary page 1.

## Most influential descendants
- 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
- 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
- K210504: PANAVIA Veneer LC (2021), 0 descendants of its own
- K191524: Visalys Tooth Primer (2019), 0 descendants of its own
- K183537: PANAVIA SA Cement Universal (2019), 0 descendants of its own

## Indications for use
Post cementation and core build-up

Source page: https://510kreport.com/device/K111982
Methodology: https://510kreport.com/methodology