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The MVP Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusion in patients with permanent dentition (i.e., all second molars). The MVP Aligners position teeth by way of continuous gentle force.

The MVP Aligner system is a prescription (Rx) device comprised of a series of dentist prescribed clear, biocompatible, plastic shells that fit over the teeth designed to incrementally improve malocclusion by providing progressive force and moving patient dentition from an initial condition to a preferred corrected condition. After a scan or physical impression of the patient's teeth is taken by or under the direct supervision of the patient's orthodontically trained dentist, each aligner in the sequential set is created by a trained technician utilizing Ortho System software (K180941) according to the orthodontic screening and tooth movement recommendations provided by the same prescribing orthodontically trained dentist. The recommendations are patient specific and can only be relied upon for an individual patient for whom the device is prescribed. Furthermore, the orthodontically trained dentist reviews and approves the model scheme before the molds are produced. Once approved, the trays which are formed of clear, thin, thermoformed plastic are fabricated.

The indirect fabrication process involves a 3D print of a plastic model representing the patient specific upper and lower dentition of the patient's jaw. The models are cured. Biocompatible plastic sheets are thermoformed over the cured models with pressure and heat, marked with a patient identifier on the occlusal surface, and trimmed in a 5-axis CNC machine. The aligner containing an individualized trim line is polished, cleaned, sorted and packaged with a UDI.

MVP Aligners are provided non-sterile and are completely removable by the patient. Once approved, the trays are sent back to the orthodontically trained dentist who then provides them to the patient, in sequential stages confirming fit and design. The orthodontically trained dentist monitors treatment from the delivery of the first to final aligner.

This document is a 510(k) Pre-market Notification summary for MVP Aligner System, seeking substantial equivalence to existing devices. As such, it does not contain information about a study proving that the device meets acceptance criteria for an AI/ML powered device, nor does it contain a table of acceptance criteria or performance metrics for such a device.

The "Clinical Data" section explicitly states: "The performance of sequential aligners in the clinical environment has been well established since the first aligners were cleared by the FDA under product code NXC in 1998. There is sufficient information available from scientific literature to support safety and efficacy. Therefore, clinical testing was not necessary to demonstrate substantial equivalence of the MVP Aligners to the predicate device."

This means:

• No specific acceptance criteria or device performance data is presented. The device is considered substantially equivalent based on its similarities to already cleared devices and existing scientific literature on aligners in general.
• No study to prove the device meets acceptance criteria was conducted or necessary according to this document. The FDA cleared this device based on predicate similarity, not on a new clinical study.
• All other points in your request (sample size, data provenance, number of experts, adjudication, MRMC study, standalone performance, ground truth, training set size, training ground truth) are not applicable because no such clinical study for this specific device's performance was performed or submitted as part of this 510(k).

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