LogoFDA 510(k) Search
K Number
K013997
Device Name
UNIFIL BOND
Manufacturer
GC AMERICA, INC.
Date Cleared
2002-02-20

(78 days)

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

Unifil Bond is a light-cured dentin bonding system to provide effective bonding to resin composite restorative materials.

Device Description

Not Found

AI/ML Overview

This is a 510(k) premarket notification for a dental bonding agent, Unifil Bond, submitted to the FDA in 2001. The document is a regulatory approval letter and does not contain information about acceptance criteria or performance studies of the device.

Therefore, I cannot extract the requested information from the provided text. The document confirms the device is substantially equivalent to legally marketed predicate devices, but it does not detail any specific studies, acceptance criteria, or performance metrics.

§ 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.