(146 days)
The 2 bond 2 system is used for the seating of non-metal, laboratory fabricated restorations such as: Artglass, porcelain, ceramic and composite inlays, onlays, veneers, crowns, and bridges.
2 bond 2 is used for the seating of metal-supported, laboratory fabricated restorations such as: crowns, bridges, inlays/onlays Maryland bridges, brackets and splints.
Not Found
This document is a 510(k) clearance letter from the FDA for a dental bonding system called "2 bond 2." It does not contain any information about acceptance criteria, device performance studies, or clinical trial details. The letter is an administrative document indicating that the device has been cleared for market based on substantial equivalence to a predicate device.
Therefore, I cannot provide the requested information based on the provided text. To answer your questions, I would need a technical document, a clinical study report, or a summary of safety and effectiveness for the "2 bond 2" device, which typically accompanies a 510(k) submission but is not included in this clearance letter.
§ 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.