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For use as a dental cement in various applications, including luting, repair of fractured porcelains or crown and bridge resins, cementaiton of adhesive bridge prostheses and CR core posts.

The product is a self curing dental cement for use in the cementation of dental devices, luting, repair of fractured porcelains or crown and bridge resins, cementation of adhesive bridges and CR core posts.

The provided text is a 510(k) summary for a dental cement called Bistite II SC. It outlines the product's intended use, substantial equivalence to other marketed devices, and regulatory approval. However, it does not contain any information about acceptance criteria, device performance metrics, or the details of a study that would demonstrate the device meets such criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

The document primarily focuses on:

• Product Identification: Bistite II SC, a self-curing dental cement.
• Intended Use: Cementation of dental devices, luting, repair of fractured porcelains or crown and bridge resins, cementation of adhesive bridges, and CR core posts.
• Regulatory Status: Substantially equivalent to previously marketed dental cement products (Panavia 21, Panavia EX, C&B Metabond).
• Contraindications and Warnings: Hypersensitivity to methacrylate monomers, avoid contact with skin/eyes.
• Regulatory Approval: Received approval from the Japanese Government and FDA 510(k) clearance.

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