(50 days)
Ufi Gel C is intended for use as a permanently soft relining for total and partial dentures.
- to relieve pressure from pressure spots
- to dam the palatal vibrating line in cases of flabby ridge and insufficient adhesion
- to cushion sharp-edged alveolar processes
- to support the healing process in implantology
Not Found
The provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device called "UFI Gel C." This document does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device.
The letter is a regulatory approval for marketing the device based on a determination of substantial equivalence to a predicate device marketed before May 28, 1976. It outlines the general controls and potential additional controls applicable to the device.
Therefore, I cannot fulfill the request to describe acceptance criteria and a study that proves the device meets them, as this information is not present in the provided document. The request specifically asks for details relevant to AI/ML device studies (e.g., sample sizes, ground truth, experts, MRMC studies, standalone performance), none of which are mentioned here.
§ 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.