Search Results

The Lin/Liou Orthodontic Mini Anchor System (LOMAS) (Sterile) is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. The device is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding the Lin/Liou Orthodontic Mini Anchor System (LOMAS). This type of document establishes substantial equivalence to a predicate device and permits marketing. It does not contain information on acceptance criteria, a study proving device performance, or any of the detailed study parameters requested in your prompt.

The letter is a regulatory approval document and not a scientific study report. Therefore, I cannot extract the requested information from the provided text.

Ask a specific question about this device

The Lin/Liou Orthodontic Mini Anchor System (LOMAS) is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. The device is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only

Lin/Liou Orthodontic Mini Anchor System (LOMAS)

I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, study design, or ground truth establishment. The document is an FDA 510(k) clearance letter for the "Lin/Liou Orthodontic Mini Anchor System (LOMAS)," confirming its substantial equivalence to a predicate device and outlining regulatory information. It does not include details about device testing or specific performance metrics.

Ask a specific question about this device