FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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.

Device Description

Supremcast Alloy is a Dental Ceramic Casting Alloy.

AI/ML Overview

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.

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K Number

K001383

Device Name

SUPREMCAST V

Manufacturer

AMERICAN DENT-ALL, INC.

Date Cleared

2000-07-05

(64 days)

Product Code