# K051796: Clearfil Tri-S Bond Single Dose

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Medical Kurashiki Plant
- Decided: Aug 9, 2005 after 35 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: 1 generation back to K042913 (2004). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042913: Clearfil Tri-S Bond, Kuraray Medical, Inc. (2004) Summary page 1.

## Most influential descendants
- K082753: Futurabond M/Futurabond M Single Dose (2008), 0 descendants of its own

## Indications for use
Clearfil tri-S bond Single dose 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) Core build-ups using light- or dual-cured composite resin

Source page: https://510kreport.com/device/K051796
Methodology: https://510kreport.com/methodology