Search Results

The uLab Systems Dental Aligner is indicated for the alignment of permanent teeth during orthodontic treatment of malocclusions by way of continuous gentle forces.

The uLab Systems Dental Aligner Kit is an orthodontic treatment system, that consists of doctorprescribed, clear, thin, plastic removable aligners. Patients are seen in a dental office where a dental professional (dentist/orthodontist) scans or takes a physical impression of the teeth, which is then used to fabricate the aligners. The aligners are designed and custom-made by dental professionals using uLab Systems proprietary technology. The aligners are made of aesthetic and medical grade materials chosen by doctors for their patients. During the orthodontic treatment, each preformed plastic aligner is worn in sequence by the patient as prescribed by the dental practitioner, moving the patient's teeth gradually to the ideal position.

The provided document does not describe a study that proves the device meets specific acceptance criteria in the context of AI performance for a diagnostic or treatment planning system.

The document is a 510(k) summary for the ULab Systems Dental Aligner Kit, a physical medical device (clear aligners) used for orthodontic treatment. The "performance data" section focuses on biocompatibility, design verification, user validation, packaging verification, and physical properties testing for the physical aligner product itself, not the performance of an AI algorithm in a diagnostic or treatment planning capacity.

Therefore, I cannot extract the requested information regarding AI acceptance criteria and study details from this document. The document describes the aligners as "designed and custom-made by dental professionals using uLab Systems proprietary technology," and mentions "dental software, the uLab Systems uDesign, K171295, for tooth alignment." However, it does not provide details on the AI performance or any studies related to its AI components.

Ask a specific question about this device