Search Results

Both the predicate turbines and the proposed Star Dental replacement turbines are intended to be used as components to high speed handpieces, which are used intraorally by trained dental professionals for drilling and preparation of dental cavities for restoration, such as fillings.

Star Dental Pushbutton Autochuck Replacement Turbine.

The provided text is a 510(k) summary for a dental device (Star Dental Pushbutton Autochuck Replacement Turbine). It describes the device, its intended use, and claims substantial equivalence to predicate devices.

However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth, expert opinions, or any of the other specific details requested in the prompt.

Therefore, I cannot provide the requested information. The 510(k) summary focuses on demonstrating equivalence to existing devices rather than presenting detailed performance studies against specific acceptance criteria.

Ask a specific question about this device