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K Number
K120134
Device Name
IPS E.MAX PRESS MULTI
Manufacturer
IVOCLAR VIVADENT AG
Date Cleared
2012-06-25

(160 days)

Product Code
EIH
Regulation Number
872.6660
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

IPS e.max Press and IPS e.max Press Multi is an all-ceramic system for the creation of
Occlusal veneers
Thin Veneers
Veneers
Inlays
Onlays
Crowns in the anterior and posterior region
3-unit bridges in the anterior region
3-unit bridges in the premolar region up to the second premolar as the terminal abutment
Crown, splinted crown or 3 unit bridge up to the second premolar placed on top of an implant abutment.

Device Description

Not Found

AI/ML Overview

The provided document is an FDA 510(k) clearance letter for a dental device (IPS e.max Press and IPS e.max Press Multi). It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter confirms substantial equivalence to a predicate device and outlines regulatory responsibilities.

Therefore, I cannot provide the requested information.

§ 872.6660 Porcelain powder for clinical use.

(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.