(40 days)
Quadrant UniBond is used in the adhesive restorative technique for bonding of dental composite restorations to tooth tissue and for sealing of exposed root surfaces.
Quadrant UniBond is used in the so-called "total etch technique", in combination with an etching agent such as Quadrant Total Etch. Conditioning of the enamel and dentin with this technique will enable the bonding agent to penetrate and seal off the cavity wall, thus forming an adhesive layer for the composite filling material.
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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental adhesive device called "Quadrant UniBond." It does not contain any information regarding acceptance criteria, study data, sample sizes, ground truth establishment, or any of the other details requested in your prompt. This document is purely administrative, confirming that the device is substantially equivalent to previously marketed devices.
§ 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.