# K111975: Clearfil Tri-S Bond Plus Single Dose Standard / Value / Introductory Pack

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Medical, 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.
No later device cites it as a predicate yet.
0 of 28 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.

## Indications for use
(1) Direct restorations using light-cured composite resin (2) Cavity sealing as a pretreatment for indirect restorations (3) Treatment of exposed root surfaces (4) Intraoral repairs of fractured restorations made of porcelain, ceramic or composite resin (5) Surface treatment of non-precious metal posts (6) Post cementation and core build-ups using dual-cured composite resin CLEARFIL DC CORE PLUS (7) Core build-ups using light-cured composite resin

Source page: https://510kreport.com/device/K111975
Methodology: https://510kreport.com/methodology