(33 days)
Versyo.bond is 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 based on the provided document, I cannot fulfill your request. The document is a 510(k) premarket notification approval letter for a dental bonding agent named "Versyo®.bond". It confirms the device's substantial equivalence to a legally marketed predicate device and outlines regulatory compliance requirements.
However, the document does not contain any information about clinical studies, performance data, acceptance criteria, sample sizes, ground truth establishment, or expert qualifications. The approval letter is a regulatory document, not a scientific study report.
Therefore, I cannot extract the specific details you've requested regarding acceptance criteria and a study proving device performance because that information is not present in the provided text.
§ 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.