Search Results

OsseoConduct is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. Specifically, for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oral, maxillofacial and dental intraosseous defects including ridge augmentation, sinus lifts, craniofacial augmentation, filling of defects of endodontic origin, filling of cystic defects, filling of extraction sites, filling of lesions of periodontal origin, repair of traumatic defects of the alveolar ridge, filling of resection defects from bone tumors, cysts or other osseous defects, and a substitute for autogenous or allogenic bone grafts.

Not Found

This document is a 510(k) clearance letter for a medical device (OsseoConduct), not a study report detailing acceptance criteria or device performance data. Therefore, the requested information cannot be extracted from the provided text.

The letter confirms that the FDA has determined the device is substantially equivalent to legally marketed predicate devices and can be marketed. It discusses regulations and responsibilities but does not contain the specific study details you're looking for.

To answer your questions, I would need a clinical study report or a summary of safety and effectiveness data for the OsseoConduct device.

Ask a specific question about this device