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

The product is a dental cement which can be either light cured or self cured.

The provided text is a 510(k) Pre-Market Notification for a dental cement (Bistite II DC). It outlines the intended use, safety information, and substantial equivalence to other marketed devices. However, the document does not contain the results of a study demonstrating that the device meets specific acceptance criteria.

The 510(k) summary (Exhibit D) and the FDA's response letter (Pages 1 & 2) primarily focus on:

• Device Description: What the device is (a dental cement), its intended use (luting, repair of fractured bridges, etc.), and user (dental practitioners).
• Substantial Equivalence: Listing predicate devices to which Bistite II DC is claimed to be substantially equivalent (Bistite II SC, Panavia 21, C&B Metabond).
• Safety Information: Contraindications and precautions.
• Regulatory Classification: The FDA confirms the device's classification (Class II, Product Code EMA, Regulation Number 872.3275).

Therefore, I cannot provide the requested information about acceptance criteria and a study proving their fulfillment because this data is not present in the provided text.

To answer your request, a document detailing performance testing, clinical studies, or engineering bench testing with defined acceptance criteria and their outcomes would be necessary.

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