# K043177: Cleafil DC Core Automix

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Medical, Inc.
- Decided: Dec 17, 2004 after 31 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
No predicates in its family tree.
13 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K062410: Clearfil Esthetic Cement & DC Bond (2006), 10 descendants of its own
- K081583: Clearfil SA Cement (2008), 9 descendants of its own
- K111982: Clearfil DC Core Plus (2011), 6 descendants of its own
- K120379: Panavia SA Cement Automix Value Pack (Universal (A2), White) Panavia SA Cement Automix (Universal (A2), White) Panavia S (2012), 5 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

## Indications for use
CLEARFIL DC CORE AUTOMIX is indicated for the following application: 1) Core build-up of vital or non-vital tooth

Source page: https://510kreport.com/device/K043177
Methodology: https://510kreport.com/methodology