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DBX® Putty and Paste are intended for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oral/maxillofacial and dental intraosseous defects including: Ridge augmentation, Filling of extraction sites, Craniofacial augmentation, Mandibular reconstruction, Repair of osseous defects of the jaws, Filling of cystic defect, Filling of lesions of periodontal origin, Filling of defects of endodontic origin, Repair of traumatic defects of the alveolar ridge, excluding maxillary and mandibular fracture, Filling of resection defects in benign bone tumors, benign cysts or other osseous defects in the alveolar ridge wall. DBX® Mix is intended for mandibular reconstruction only. DBX® is intended for single patient use only.

DBX® is intended for single patient use only. DBX® Demineralized Bone Matrix is available in three forms: Paste, Putty and Mix. DBX® products are completely resorbable. DBX® Paste and Putty are composed of processed human cortical bone; the DBX® Mix is composed of processed human corticocancellous bone. The bone granules are mixed with sodium hyaluronate ("NaHA") in varying combinations to form the DBX® Putty, Paste and Mix. All versions of DBX® are available in five sizes. DBX® is osteoconductive and has been shown to have osteoinductivity potential in the athymic mouse model. It is unknown how the osteoinductivity potential, measured in the athymic mouse model, will correlate with clinical performance in human subjects.

This document is a 510(k) summary for the DBX® Demineralized Bone Matrix product. It describes the device, its intended use, and its substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

Therefore, I cannot provide the requested information. The provided text is a regulatory submission for a medical device (a 510(k) premarket notification), which typically aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than present a study against specific performance acceptance criteria.

The information you've asked for (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) are commonly found in clinical study reports or performance testing documentation for devices that have undergone such evaluations. This 510(k) summary does not include that level of detail regarding device performance or formal studies as would be expected for demonstrating adherence to specific acceptance criteria.

Key takeaway from the document:

• Device: DBX® Demineralized Bone Matrix (Putty, Paste, and Mix).
• Intended Use: Augmentation of deficient maxillary and mandibular alveolar ridges and treatment of various oral/maxillofacial and dental intraosseous defects.
• Regulatory Decision: The FDA determined the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.
• Performance Claim: The device is osteoconductive and has shown osteoinductive potential in an athymic mouse model, but it is unknown how this correlates with human clinical performance. It has not been proven osteoinductive in a human model.

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