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Straumann® 4 mm Short Implants are intended for oral endosteal implantation in the jaw and for the functional oral rehabilitation of edentulous and partially edentulous patients.

Straumann® 4 mm Short Implants are indicated for fixed or removable reconstruction in situations of moderate to severely atrophic jawbone and with adequate bone quality that allows primary stability after implant insertion, where a longer implant cannot be placed due to limited vertical bone height. The recommended healing time before loading is between 10 to 12 weeks. The 4 mm Short Implants are specifically recommended for:

• Fixed partial dentures/splinted units (one implant per unit)
• Pontic cases in combination with at least one longer implant
• Fully edentulous cases with at least one 4 mm Short Implant in combination with 2 longer implants in the anterior region and at least four total implants

The Straumann® Dental Implant System is an integrated system of endosseous dental implants with corresponding abutments, healing abutments, closure screws and surgical and prosthetic parts and instruments. Straumann® Roxolid® dental implants are solid screw implants comprised of a titanium-zirconium alloy with the hydrophilic SLActive® bone anchorage surface that is large-grit sandblasted and acid-etched. In addition, SLActive® is in a chemically activated state, which is preserved by storage in a NaCI solution.

This premarket notification serves to add new dental implants to the Straumann Dental Implant System portfolio that are 4 mm in length. Other than the implant length, the subject devices are physically identical to the primary predicate tissue level devices except for the implant thread which is identical to the bone level primary predicate devices cleared under K130222.

The Straumann® 4 mm Short Implants are manufactured from the Roxolid® material with the SLActive® surface and are available in Ø4.1 mm with a Regular Neck (RN) Tissue Level implant/abutment interface and in Ø4.8 mm with an RN or Wide Neck (WN) Tissue Level implant/abutment interface.

The provided text does NOT describe an AI/ML powered device, therefore, the requested information elements related to AI/ML device performance and testing (such as AI assistance effect size, ground truth for training/test sets, sample sizes for training/test sets, adjudication methods, and expert qualifications) cannot be extracted or fulfilled.

The document pertains to the 510(k) summary for Straumann® 4 mm Short Implants, a medical device, and the evaluation details focus on the physical and mechanical performance of the implant, biocompatibility, sterilization, and clinical literature review of implant survival rates, not on an AI system's performance.

Therefore, the table of acceptance criteria and reported device performance, and the other requested information points are not applicable in the context of an AI/ML device. The document describes a dental implant, not an AI or imaging device.

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