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K Number
K103528
Device Name
IPS EMPRESS DIRECT FLOW
Manufacturer
IVOCLAR VIVADENT, INC.
Date Cleared
2011-02-25

(87 days)

Product Code
EBF,EBC,EBD
Regulation Number
872.3690
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

As an intermediate or covering layer in the fabrication of esthetically demanding composite restorations
Repair of composite restorations (in particular filling of voids, levelling out of porosities and minor chips)
As a thin (

Device Description

Not Found

AI/ML Overview

This document describes the FDA's 510(k) clearance for the IPS Empress Direct Flow device. It does not contain information about acceptance criteria, device performance studies, or details regarding ground truth establishment, sample sizes, or expert qualifications as it pertains to a study in the context of AI/ML device approval.

Therefore, I cannot provide the requested information. The document is a regulatory clearance letter, not a study report.

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.