# K980232: Clearfil DC Cement

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Company, Ltd.
- Decided: Feb 24, 1998 after 33 days
- Product code: EMA (Cement, Dental)
- Device class: 2
- Regulation: 21 CFR 872.3275
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 1 cites it directly.
0 of 13 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
- K012735: Clearfil DC Cement (2001), 11 descendants of its own
- 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

## Indications for use
1) Porcelain inlay cementation 2) Composite resin inlay cementation 3) Jacket crown cementation with porcelain or composite resin

Source page: https://510kreport.com/device/K980232
Methodology: https://510kreport.com/methodology