(16 days)
Expa-syl is a paste containing aluminum chloride which is intended to be used for the temporary retraction and hemostasis of the gingival margin during dental procedures such as, but not limited to, dental impressions, seating of temporary and permanent restorations, restorations of cavities and placement of a rubber dam.
Expa-syl is a paste containing aluminum chloride which is used for the temporary retraction and hemostasis of the gingival margin during dental procedures such as, but not limited to, dental impressions, seating of temporary and permanent restorations, restorations of cavities and placement of a rubber dam. The paste is extruded through the tip attached to the cartridge and applied into the sulcus through the use of the manual dispensing gun. The paste is left in place between 1 to 2 minutes, depending upon the tonicity of the marginal gingiva, and then removed by an air and water spray with simultaneous aspiration. A dry, retracted sulcus is obtained.
The provided text is a 510(k) summary for a dental product called Expa-syl. It describes the device, its intended use, and claims substantial equivalence to existing products. However, the document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is solely focused on regulatory submission for substantial equivalence.
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