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Quick Coupling For Dental Prostheses

This letter is a 510(k) clearance letter from the FDA, not a study report. Therefore, it does not contain the information requested about acceptance criteria, device performance, study design, or ground truth establishment.

To answer your questions, I would need to analyze a different document, specifically a study report or a 510(k) submission that details the clinical or performance testing conducted for the "Quick Coupling For Dental Prostheses."

This letter simply states that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It does not provide any performance data or study details.

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Device For Providing Quick Coupling For Dental Prostheses

The provided text is a letter from the FDA to Dr. Joseph E. Grasso regarding the substantial equivalence of a "Device For Providing Quick Coupling For Dental Prostheses" (K950261).

This letter serves as a premarket notification approval and does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, it is impossible to answer any of the questions from the input based on the provided text.

Ask a specific question about this device

Ask a specific question about this device