CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack

• K Number: K161042
• Device Name: CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack
• Manufacturer: Kuraray Noritake Dental, Inc.
• Date Cleared: 2016-10-25 ( 195 days)
• Product Code: KLE
• Regulation Number: 872.3200
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended 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

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a dental bonding agent (CLEARFIL Universal Bond Quick) and focuses on regulatory approval rather than a detailed study report with performance metrics, sample sizes, or ground truth establishment.

Regulation Number and Section

§ 872.3200 Resin tooth bonding agent.

(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.