# K111980: Clearfil Tri-S Bond Plus

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray America, Inc.
- Decided: Oct 14, 2011 after 94 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: 8 generations back to K931812 (1993). 27 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 32 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.
- K062382: Clearfil DC Bond, Kuraray Medical, Inc. (2006) Summary page 1.
- K032455: Panavia F 2.0, Kuraray Medical, Inc. (2003) Summary page 1.
- K063593: Clearfil Majesty Flow, Kuraray America, Inc. (2007) Summary page 1.

## Most influential descendants
- K132450: Clearfil Universal Bond Value Pack, Clearfil Universaly Bond Trial, Clearfil Universal Bond (2013), 1 descendant of its own
- K131432: Clearfil SE Bond 2 Kit; Clearfil SE Bond 2 Value Pack; Clearfil SE Bond 2 Trial Pack; Clearfil SE Bond 2 Bond; Clearfil (2013), 1 descendant of its own
- K231696: Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal (2023), 0 descendants of its own
- K192913: R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose (2021), 0 descendants of its own

## Indications for use
Direct restorations using light-cured composite resin Cavity sealing as a pretreatment for indirect restorations Treatment of exposed root surfaces Intraoral repairs of fractured restorations made of porcelain, ceramic or composite resin Surface treatment of prosthetic restorations made of porcelain, ceramic or composite resin Surface treatment of dental posts Post cementation and core build-ups using dual-cured composite resin CLEARFIL DC CORE PLUS Core build-ups using light-cured composite resin

Source page: https://510kreport.com/device/K111980
Methodology: https://510kreport.com/methodology