# K161042: CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Noritake Dental, Inc.
- Decided: Oct 25, 2016 after 195 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K231039: CLEARFIL Universal Bond Quick 2 (2023), 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] Intraoral repairs of fractured restorations [6] Post cementation and core build-ups [7] Cementation of indirect restorations

Source page: https://510kreport.com/device/K161042
Methodology: https://510kreport.com/methodology