(78 days)
Quick Up is intended for the following applications:
- The gingival-coloured self-curing SC material is used for cementing attachments, such as ball, locator and telescopic anchors as well as other anchors in compositebased dentures.
- The gingival-coloured light-curing LC material can be used for subsequent corrections.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for a dental device called "Quick Up." This kind of document typically focuses on establishing substantial equivalence to a predicate device rather than presenting detailed study results with acceptance criteria.
Therefore, the information required to answer your questions regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is not available within this document.
This document confirms that the device is a "Denture Relining, Repairing, or Rebasing Resin" and is intended for cementing attachments in composite-based dentures and for subsequent corrections. It also states the device is "Prescription Use."
To obtain the information requested, one would need to refer to the actual 510(k) submission document (K110440) itself, which would contain the technical data and study reports.
§ 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.