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For immediate or delayed placement and function on single-tooth and/or multiple tooth applications in the maxillary and or mandibular arches to support crowns, bridges, and overdentures in edentulous or partially edentulous patients. Immediate loading is indicated for single tooth and/or multiple tooth applications when there is good primary stability and an appropriate occlusal load.

The DenovisMed Dental Implant System is intended to support prosthetic devices in edentulous or partially edentulous patients to restore esthetics and chewing function. The System consists of the DenovisMed Dental Implant, a self-tapping, threaded, root-formed dental implant as well as straight abutments and related prosthetic components.

The provided text describes the DenovisMed Dental Implant System, a medical device. However, it does not contain any information about acceptance criteria, device performance, or any studies conducted to prove the device meets acceptance criteria.

The document is a 510(k) summary and an FDA clearance letter, which focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting performance study data against defined acceptance criteria.

Therefore, I cannot fulfill your request for the specific details outlined (acceptance criteria table, study sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set size, and ground truth establishment for the training set) because this information is not present in the provided text.

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