Search Results

Mycone Dental's denture material, known as Diamond D, is intended to form new dentures or to repair fractured dentures. It is to be used only by professional dental practitioners who make or repair dentures for patients.

Not Found

This document is a 510(k) clearance letter from the FDA for a dental device called "Diamond D High Implant Denture Material." It indicates that the device has been found substantially equivalent to a predicate device. However, the letter does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

The document primarily states:

• The device name, regulation number, regulation name, and product code.
• The FDA's determination of substantial equivalence.
• General controls and additional controls applicable to the device.
• Contact information for further inquiries.
• The "Indications For Use" for the device, which states it is "intended to form new dentures or to repair fractured dentures" and "to be used only by professional dental practitioners who make or repair dentures for patients."

Therefore, I cannot provide the requested information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment based on the provided text. This type of detail would typically be found in the 510(k) submission document itself, not in the clearance letter.

Ask a specific question about this device