# K131430: Clearfil DC Activator; Clearfil DC Activator Trial

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Noritake Dental, Inc.
- Decided: Aug 30, 2013 after 105 days
- Product code: KLE (Agent, Tooth Bonding, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K943167 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050386: Prime & Bond NT Dual Cure Nano-Technology Universal Dental Adhesive System, Dentsply International (2005) Summary page 1.
- K012734: Clearfil New Bond, Kuraray Medical, Inc. (2001) Summary page 1.

## Indications for use
When used with the CLEARFIL BONDING SYSTEM, the product is indicated for the following uses. [I]I Core build-up in conjunction with self- or dual- cured core build-up materials [2] Cementation in conjunction with self- or dual- cured composite resin cements

Source page: https://510kreport.com/device/K131430
Methodology: https://510kreport.com/methodology