(37 days)
Versyo.direct is a light curing, methyl methacrylate free conditioner for the bonding of light curing prosthetic base materials to heat, self or light curing PMMA denture base materials and artificial teeth based on PMMA.
Not Found
I am sorry, but the provided text is a 510(k) premarket notification decision letter from the FDA for a dental bonding agent (Versyo®.direct). It does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.
The letter confirms the device's substantial equivalence to a predicate device based on its indications for use and regulatory classification. It outlines regulatory requirements for marketing the device but does not include details about performance studies, sample sizes, ground truth establishment, or expert reviews, which would typically be found in a submission summary or a scientific study report.
Therefore, I cannot provide the requested information.
§ 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.