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Superbond (Ceramic Dental Casting Alloy) is for the use in Dental Laboratories, suitable for use in fabrication of metal-ceramic dental restoration.

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This document is an FDA 510(k) clearance letter for a dental alloy named "Superbond". It's a regulatory approval, not a scientific study report describing acceptance criteria and device performance in the way you've outlined. Therefore, I cannot extract the requested information from the provided text.

The document primarily focuses on:

• Device identification: Superbond, a Ceramic Dental Casting Alloy.
• Regulatory classification: Class II, Product Code EJH.
• Substantial equivalence determination: The FDA found it substantially equivalent to legally marketed predicate devices.
• Intended use: For use in Dental Laboratories, suitable for use in the fabrication of metal-ceramic dental restoration.
• Regulatory compliance: Information about general controls provisions and other FDA regulations.

It does not contain any information about:

• Specific acceptance criteria for performance metrics (e.g., accuracy, sensitivity, specificity).
• Results of a study proving the device meets acceptance criteria.
• Sample sizes, data provenance, expert qualifications, or adjudication methods for a test set.
• MRMC studies or standalone algorithm performance.
• Ground truth types or training set details.

To address your request, a different type of document, such as a clinical study report, a technical performance study report, or the 510(k) summary (which sometimes includes more detail on performance data if applicable to the device type), would be needed.

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Flexicast Prime ( Partial Denture Dental Casting Alloy ) is for use in dental laboratories, suitable for preparation of removable dental appliances.

Flexicast Prime ( Partial Denture Dental Casting Alloy )

I am sorry, but the provided text does not contain the detailed information required to answer your request about acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for a dental casting alloy named "Flexicast Prime."

It confirms the device's substantial equivalence to a predicate device and its regulatory classification. However, it does not include:

• A table of acceptance criteria or reported device performance.
• Details about a study, sample sizes, data provenance, expert qualifications, or ground truth establishment.
• Information on MRMC studies or standalone algorithm performance.

The letter explicitly states that it is a response to the premarket notification submission and that "The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market." This type of document typically does not elaborate on the specific performance studies that were submitted to demonstrate substantial equivalence, but rather notifies the applicant of the FDA's decision.

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Supremcast Alloy is a Dental Ceramic Casting Alloy. For use in dental laboratories. Suitable for use in fabrication of ceramic fused to metal Dental restoration.

Supremcast Alloy is a Dental Ceramic Casting Alloy.

I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a dental alloy named "Supremcast." It confirms the device's substantial equivalence to legally marketed predicate devices and allows it to be marketed.

However, the letter does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications. Therefore, I cannot extract the requested information to fill out the table and answer the specific questions about a device study.

The document is purely a regulatory approval letter and does not include the technical study details that would typically be found in a clinical trial report or a scientific publication.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device