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Hemostasyl Paste achieves its hemostatic effect in the gingival sulcus by physical and mechanical means during dental procedures such as dental impressions, scaling, seating of temporary and permanent restorations, and placement of a rubber dam.

HEMOSTASYL is an original paste presented in syringes. It is designed to be used as a haemostatic dressing through two mechanisms of action. One is mechanical: it is achieved due to the viscosity and adhesiveness of the paste (clogging effect); the other is due to astringent properties of the aluminium chloride, which result in contraction of tissues and blood vessels. The main characteristics of HEMOSTASYL are as follows: thixotropic properties, good adhesion to the gingival mucosa, without compression, presence of aluminium chloride which reinforces its mechanical haemostatic effect, easily removed by gentle water spray without resumption of bleeding, painless method when HEMOSTASYL is used on a healthy periodontium, contact time: 2 minutes.

This document describes the HEMOSTASYL Paste, a dental hemostatic agent, and its substantial equivalence to a predicate device, EXPASYL. However, it does not contain information about studies with acceptance criteria or performance metrics for the HEMOSTASYL Paste itself. Instead, the submission relies on demonstrating substantial equivalence to a previously cleared device.

Therefore, I cannot provide a response filling in the requested table and study details directly from the provided text. The document primarily focuses on:

• Device Description: Explaining the composition, properties (thixotropic, adhesiveness, aluminum chloride content), and mechanism of action (mechanical clogging and astringent effect).
• Intended Use: For achieving hemostatic effect in the gingival sulcus during various dental procedures.
• Substantial Equivalence: Stating that HEMOSTASYL is substantially equivalent to EXPASYL based on similar intended use and function.

The provided text does not include any clinical study data, performance metrics, acceptance criteria, sample sizes for testing or training, expert ground truth establishment, or MRMC studies for HEMOSTASYL Paste. The FDA clearance letter confirms that the device was found substantially equivalent to a predicate, which means it didn't necessarily require new clinical performance data to be submitted for its own clearance, but rather a demonstration that it is as safe and effective as a legally marketed device.

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