(83 days)
This device/method is a means of conditioning enamel and dentin to Obtain adhesive bonding of polymeric materials. It is used by dental professionals in restorative procedures.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding a dental product named "Sure Bond." This document does not contain any information about acceptance criteria, study details, or device performance metrics.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets those criteria, as the necessary information is absent from the provided text.
The document only states that:
- The device is substantially equivalent to a legally marketed predicate device.
- The device's intended use is "a means of conditioning enamel and dentin to obtain adhesive bonding of polymeric materials. It is used by dental professionals in restorative procedures."
§ 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.