(3 days)
Adhesion to Dentin Of various polymeric filling materials (composites) used with other conditioners or combination of conditioners for bonding of composite to metal including amalgam, gold, sami precious, and non-precious alloys, porcelain and glass and luting of same to Dentin and Enamel.
Not Found
This document is a 510(k) clearance letter from the FDA for a dental product called "Bond 1". It indicates that the device is substantially equivalent to existing devices. However, it does not contain any information regarding acceptance criteria or the specific studies used to prove device performance.
Therefore, I cannot provide the requested information based on the input text. The document primarily focuses on regulatory approval and classification, not on the detailed technical specifications and performance data of the device.
§ 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.