# K132450: Clearfil Universal Bond Value Pack, Clearfil Universaly Bond Trial, Clearfil Universal Bond

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Noritake Dental, Inc.
- Decided: Nov 1, 2013 after 87 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: 9 generations back to K931812 (1993). 32 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111980: Clearfil Tri-S Bond Plus, Kuraray America, Inc. (2011)
- K042913: Clearfil Tri-S Bond, Kuraray Medical, Inc. (2004) Summary page 1.
- K061906: Clearfil Ceramic Primer, Kuraray Medical, Inc. (2006) Summary page 1.
- (no number) Scotebbond Universal Adhesive: named in the summary without a submission number

## Most influential descendants
- 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
[1] Direct restorations using light-cured composite resin [2] Cavity sealing as a pretreatment for indirect restorations [3] Treatment of exposed root surfaces [4] Treatment of hypersensitive teeth [5] lntraoral repairs of fractured restorations [6] Post cementation and core build-ups [7] Cementation of inlays, onlays, crowns, bridges and veneers

Source page: https://510kreport.com/device/K132450
Methodology: https://510kreport.com/methodology