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Straumann® BoneCeramic is indicated for filling and/or augmenting the following intraoral/maxillofacial osseous defects:

• Intrabony periodontal osseous and furcation defects
• Augmentation of bony defects of the alveolar ridge ●
• Filling tooth extraction sites ●
• Sinus elevation grafting .

Straumann® BoneCeramic is a fully synthetic bone graft substitute of medical grade purity in particulate form composed of biphasic calcium phosphate. It consists of a mixture of 60% hydroxyapatite (HA), which is 100% crystalline, and of 40% of the beta form of tricalcium phosphate (beta-TCP). BoneCeramic is 90% porous with interconnected pores of 100-500 microns in diameter. It is osteoconductive and gradually resorbed and replaced by vital bone during bone remodeling.
BoneCeramic is available in two granule sizes: 400-700 µm diameter and 500-1000 µm diameter and in three different filling volumes: 0.25g, 0.5g and 1.0g. It is delivered sterile.

This document is an FDA 510(k) summary for the Straumann® BoneCeramic device. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove performance against specific acceptance criteria for a novel device. Therefore, many of the requested elements are not applicable in the context of this 510(k) summary.

However, based on the provided text, here’s an analysis:

1. A table of acceptance criteria and the reported device performance

The document does not present specific acceptance criteria in a quantitative table format with corresponding device performance metrics for a clinical study. Instead, it relies on demonstrating substantial equivalence to a legally marketed predicate device (K040646 Straumann Granules) by showing similar technological characteristics and relying on the predicate's established safety and effectiveness.

The "reported device performance" is primarily qualitative and inferred from the long-term use of the predicate device and the new device sharing similar characteristics.

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