Search Results

Ask a specific question about this device

Enlight LV is a light-cured, two component, orthodontic bonding adhesive and Enlight EV IS a light ourou, two con attachment of orthodontic appliances to teeth.

The device is a visible light-cured, two component, orthodontic bonding adhesive. It is specifically designed to be used for the attachment of orthodontic appliances to teeth. The product has excellent handling characteristics, highly desirable curing properties and a high bond strength.

The provided text is a 510(k) summary for a medical device called "Enlight LV," an orthodontic bracket adhesive and sealant. The document is a regulatory submission to the FDA, demonstrating substantial equivalence to a predicate device. It does not contain information about a clinical study, acceptance criteria, or performance data in the context of device efficacy or accuracy, which would be typical for an AI-powered diagnostic or predictive device.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on demonstrating equivalence rather than a detailed performance study against acceptance criteria.

Ask a specific question about this device