Search Results

Straumann® dental implants are suitable for the treatment of oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients (unless specific indications and limitations are present, as stated below). Straumann® dental implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments). When placing implants in the posterior region, we recommend using only large diameter implants. In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases.

Specific indications for small diameter (Ø 3.3 mm) implants: Because of their reduced mechanical stability, small diameter implants are only used in cases with a low mechanical load. Placement in the molar region is not recommended.

The Straumann Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments and surgical and prosthetic parts and instruments.

The provided text is a 510(k) summary for the Straumann Dental Implant System. It describes the device, its intended use, and its equivalence to predicate devices. However, it does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The document is a regulatory submission for a medical device (dental implants) and focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than presenting performance data against predefined acceptance criteria for a new type of study or algorithm. This type of submission typically relies on existing standards, materials testing, and clinical history of the predicate devices.

Therefore, I cannot provide the requested information from the given text. The sections requested, such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and how ground truth was established, are not present in this 510(k) summary.

Ask a specific question about this device