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). Strauman® 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.

This document is a 510(k) summary for a medical device, the Straumann Dental Implant System. It does not contain information about acceptance criteria or a study proving that a device meets those criteria in the context of an AI/ML-driven solution.

The provided text describes a traditional medical device (dental implants) and its regulatory review process for substantial equivalence to a predicate device. It details the device's intended use, technological characteristics, and the FDA's clearance.

Therefore, I cannot provide the requested information, such as:

• Acceptance criteria table and device performance: Not applicable for this type of document.
• Sample size and data provenance for a test set: No test set is mentioned as this device is not an AI/ML product requiring such evaluation.
• Number and qualifications of experts for ground truth: Not applicable.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study or human reader improvement with AI: Not applicable, as this is not an AI product.
• Standalone algorithm performance: Not applicable.
• Type of ground truth used: Not applicable.
• Sample size for training set and ground truth establishment for training set: Not applicable.

Ask a specific question about this device