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K Number
K984503
Device Name
ALPHA BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-000
Manufacturer
WALLACE A. ERICKSON & CO.
Date Cleared
1999-02-26

(70 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

Alpha Bond Dentin/Enamel Bonding Agent is a single solution, hydrophilic, unfilled resin that acts both as a moist dentin primer and an adhesive and is primarily used as a Primer/bonding agent between the etched dentin and/or enamel surfaces and the Restorative composite material.

Device Description

Alpha Bond Dentin/Enamel Bonding Agent is a single solution, hydrophilic, unfilled resin that acts both as a moist dentin primer and an adhesive.

AI/ML Overview

I am sorry, but the provided text does not contain any information regarding acceptance criteria for a device, nor does it describe a study that proves a device meets such criteria. The document is an FDA 510(k) clearance letter for the "Alpha Bond Dentin/Enamel Bonding Agent," indicating that the device is substantially equivalent to a predicate device.

To answer your request, I would need a different type of document, such as a clinical study report, a device validation report, or a regulatory submission that includes performance data and acceptance criteria.

§ 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.