(174 days)
Silicone Soft Reline is usesd as a soft reline material for removable dentures.
Not Found
This appears to be an FDA 510(k) clearance letter for a medical device called "Silicone Soft Reline." This type of document is a regulatory approval, not a scientific study report describing acceptance criteria and performance data. Therefore, the requested information about acceptance criteria, study details, sample sizes, expert qualifications, and ground truth cannot be extracted from this document.
The document states:
- Device Name: Silicone Soft Reline
- Intended Use: "Silicone Soft Reline is used as a soft reline material for removable dentures."
- Regulatory Determination: The device is deemed "substantially equivalent" to legally marketed predicate devices. This means its safety and effectiveness are considered comparable to devices already on the market, rather than requiring new clinical trials to establish its efficacy against specific performance metrics.
To answer your questions, one would need access to the full 510(k) submission (K981691), which may contain performance data and a comparison to a predicate device. However, this specific letter does not provide that level of detail.
§ 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.