(47 days)
TUF LiNK Silicone Reliner is applied to acrylic dentures for the purpose of providing a soft tissue-bearing surface to the denture for patient comfort.
Not Found
This document is an FDA 510(k) clearance letter for a medical device called "Tuf Link™ Resilient Silicone Reliner." It does not contain any information about acceptance criteria, device performance metrics, clinical studies, sample sizes, expert qualifications, or ground truth establishment.
The letter is a regulatory document stating that the FDA has found the device to be "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed. It refers to general controls, regulations, and advises the manufacturer on their responsibilities for registration, labeling, and good manufacturing practices.
Therefore, I cannot provide a response to your request based on the provided text, as the necessary information is not present.
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.