LogoFDA 510(k) Search
K Number
K013584
Device Name
EXCITE SELF ETCH
Manufacturer
IVOCLAR VIVADENT, INC.
Date Cleared
2002-01-28

(90 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

Excite® Self Etch is a light cured adhesive designed to bond composite and compomer to enamel and dentin. It is also an adhesive for light initiated resin cements used in conjunction with "transparent" indirect restorations, i.e. all ceramic (except zirconiumoxide) and composite restorations.

Excite Self Etch is contraindicated for use as an adhesive with self-curing resin cements. Dual curing materials must be light initiated. This product is also contraindicated for zirconiumoxide ceramic restorations and for pulp capping.

Device Description

Not Found

AI/ML Overview

This document is a FDA 510(k) clearance letter for a dental adhesive device named "Excite Self Etch". It does not contain information about acceptance criteria or a study that proves the device meets such criteria. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information.

§ 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.