# K012735: Clearfil DC Cement

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Medical, Inc.
- Decided: Sep 14, 2001 after 31 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
Longest line of descent: 1 generation back to K980232 (1998). 1 ancestor in all.
11 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)
- K980232: Clearfil DC Cement, Kuraray Company, Ltd. (1998) Summary page 1.

## 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 CEMENT is indicated for the following applications: 1) Porcelain inlay cementation 2) Composite resin inlay cementation 3) Jacket crown cementation with porcelain or composite resin

Source page: https://510kreport.com/device/K012735
Methodology: https://510kreport.com/methodology