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K Number
K052130
Device Name
VITA IN-CERAM 2000 AL CUBES FOR INLAB, MODELS AL20/AL40
Manufacturer
VIDENT
Date Cleared
2005-08-15

(10 days)

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

In-Ceram® 2000 AL CUBES for inLab® are indicated for use as a substructure for porcelain fused ceramic fixed dental restorations; for single unit anterior or posterior crowns and 3 unit anterior bridges.

Substructures of AL Cubes for Cerec are machined using the Cerec 2, Cerec 3 and InLab cad/cam systems.

For use by or on the order of a dental professional such as DDS or DMD. Not for use by the general public or OTC.

Device Description

Vita In-Ceram® 2000 AL Cubes for inLab® are indicated for use as a substructure for porcelain fused ceramic fixed dental restorations; for single unit anterior or posterior crowns and 3 unit anterior bridges. Substructures of AL Cubes for Cerec are machined using the Cerec 2, Cerec 3 and InLab cad/cam systems.

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA regarding "Vita In-Ceram® 2000 AL Cubes for inLab®". It states that the device is substantially equivalent to legally marketed predicate devices and outlines general control provisions and other regulations.

However, the document does not contain specific information about acceptance criteria, device performance metrics, sample sizes, expert qualifications, adjudication methods, or study designs (e.g., MRMC, standalone) as requested in your prompt. This type of information is typically found in the test reports, clinical study summaries, or performance sections of a 510(k) submission, but it is not detailed in the FDA's decision letter provided here.

Therefore, I cannot provide the requested table and information based on the given text. The document confirms the device's classification and allows it to be marketed, but it does not delve into the technical validation studies that led to that determination.

§ 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.