(61 days)
Dentin and Enamel adhesive for use with amalgam and resin based restorative materials.
Not Found
This an FDA approval letter for a device named Alloybond, which is a Dentin and Enamel adhesive. The letter mentions that the device is "substantially equivalent" to devices marketed before May 28, 1976. However, the provided document does not contain any information regarding acceptance criteria, device performance details, study design (sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies), or ground truth establishment for either test or training sets. This letter confirms approval and mentions that the device can be marketed.
Therefore, I cannot fulfill the request as the necessary information is not present in the provided text.
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.