(85 days)
Bond 1 C & B is used for adhesion to dentin and bonding of various polymeric filling materials (composites). Also, Bond 1 C & B is used for bonding of composite to metal, including amalgam, gold, semi precious, and non precious alloys, porcelain and glass and luting of same to Dentin and Enamel.
Bond 1 C&B contains Alcohol and Bond 1 K973388 contains Acetone. Bond 1 C&B will reduce the technique sensitivity of bonding, increasing the working time and decreasing the potential for sensitivity.
This document is a 510(k) summary for a dental bonding agent, Bond 1 C&B. It explicitly states that "No clinical performance investigations were conducted on Bond 1 C & B since it is substantially equivalent to Bond 1, K973388." Therefore, the document does not contain information about acceptance criteria or a study proving the device meets them.
The 510(k) process is used to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and technological characteristics, or different technological characteristics but is as safe and effective as the predicate device and does not raise different questions of safety and effectiveness. Clinical studies demonstrating performance are often not required for 510(k) clearances if substantial equivalence can be demonstrated through other means, such as comparison of materials, design, and indications for use.
Therefore, I cannot provide the requested information from this document.
§ 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.