(226 days)
Mycone Dental's High-Impact Denture Acrylic CAD/CAM Milling Disc material, known as Keymill, is intended to be used to form new dentures. It is intended to be used only by professional dental practitioners who make dentures for patients.
Keymill High-Impact Denture Acrylic CAD/CAM Milling Disc
The provided text is an FDA 510(k) clearance letter for a dental device called "Keymill High-Impact Denture Acrylic CAD/CAM Milling Disc." This document is a regulatory approval notice and does not contain any information about acceptance criteria or specific studies that prove the device meets those criteria.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory requirements for marketing the device. It also includes the intended use statement.
Therefore, I cannot provide the requested information based on the input text. The text does not describe:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness studies or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for a training set.
- How ground truth for the training set was established.
§ 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.