(129 days)
LANG DENTAL Acrylic Primer is intended for use as an acrylic bonding agent when adding new acrylic to existing denture base acrylic.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for a dental device (Lang Dental Acrylic Primer). This type of document does not contain any information about acceptance criteria or specific study data to prove device performance.
Instead, a 510(k) letter confirms that the FDA has reviewed the manufacturer's submission and found the device to be substantially equivalent to a legally marketed predicate device. This means the device is considered as safe and effective as existing devices on the market, based on its indications for use and technological characteristics. The letter is an official approval to market the device, subject to general controls.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications from this document. Such information would typically be found in the actual 510(k) submission itself (which is not provided here), or in a separate clinical or non-clinical study report.
§ 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.