Search Results

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.

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.

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.

Ask a specific question about this device