(71 days)
PERMAFIX is intended to permanently reline a denture surface that contacts tissue.
The product is self-curing and is intended for chairside use in dental practices and for dental laboratories. It is not intended for over-the-counter (OTC) use.
Applications
To avoid and to relieve pressure areas in the upper and lower denture
Post-damming of the A-line
Elastic cover for dentures in the upper jaw
Cushioning of overdentures that contact implants during the process of healing in the field of implantology
PERMAFIX - Chairside Soft Denture Relining Device. The reliner remains permanently soft. Material: A-Silicone.
I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for a dental relining material called "Permafix" and lists its intended use and physical characteristics. It does not include details about device performance metrics, sample sizes for testing, ground truth establishment, or any comparative effectiveness studies. Therefore, I cannot fulfill your request based on the given input.
§ 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.