(74 days)
SECURE SOFT is intended for use as 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 510(k) clearance letter from the FDA for a dental device called "Secure Soft." This document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies. The letter primarily focuses on the regulatory determination of substantial equivalence to a predicate device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the provided input. This information would typically be found in the 510(k) submission itself or in a separate study report, not in the FDA's clearance letter.
§ 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.