(42 days)
Direct bonding of light-cured composite and compomer materials, dentin sealing, direct bonding of light-cured composite to ceramics, composite, metals and amalgam.
Not Found
This is a letter from the FDA to a medical device manufacturer, indicating that their device, "Adhesive 1," has been found substantially equivalent to a legally marketed predicate device. This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It primarily focuses on the regulatory clearance for marketing the device.
Therefore, I cannot extract the requested information regarding the acceptance criteria and the study that proves the device meets them from 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.