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K Number
K042670
Device Name
FUTURABOND NR
Manufacturer
VOCO GMBH
Date Cleared
2004-11-01

(33 days)

Product Code
KLE
Regulation Number
872.3200
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Futurabond NR is intended to be applied onto the interior of a prepared cavity of a tooth to improve retention of a restoration.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a dental bonding agent, Futurabond NR. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or AI comparative effectiveness studies.

This document is a regulatory approval notice, not a scientific study report. Therefore, I cannot extract the requested information from the provided text.

§ 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.