# K042913: Clearfil Tri-S Bond

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Medical, Inc.
- Decided: Nov 26, 2004 after 36 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
No predicates in its family tree.
26 later devices descend from it; 11 cite it directly.
0 of 27 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
- K061906: Clearfil Ceramic Primer (2006), 9 descendants of its own
- K062382: Clearfil DC Bond (2006), 6 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
- K111980: Clearfil Tri-S Bond Plus (2011), 4 descendants of its own
- K081913: Metacem, Meta P&Bond, Metacem Silane Ceramic Primer (2008), 3 descendants of its own

## Indications for use
CLEARFILTRI-S BOND is indicated for the following applications: 1)Direct restorations using light-cured composite resin 2)Cavity sealing as a pretreatment for indirect restorations 3)'Treatment of exposed root surfaces 4)lntraoral repairs of fractured crowns/bridges made of porcelain or composite resin 5)Surface treatment of prosthetic appliances made of porcelain or composite resin 6)Core build-ups using light- or dual- cured composite resin

Source page: https://510kreport.com/device/K042913
Methodology: https://510kreport.com/methodology