(28 days)
Excite adhesive is for use in clinical situations in which adhesion between light initiated resin based restorative or cementation materials and dentin and enamel is desired.
- Adhesion of direct light initiated resin based restorations or repairs including: composite, ceromer and . compomer to enamel and dentin.
- Adhesion of light initiated resin based cementation materials to enamel and dentin during final . placement of indirect restorations including: veneers, inlays, onlays, and single and multiple unit restorations.
- As a resin based wetting agent to improve adhesion between silanated ceramic or ceromer surfaces . (indirect restorations, repairs) and light initiated resin cements and restoratives.
Not Found
I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study proving the device meets them. The document is an FDA 510(k) clearance letter for the "Excite" adhesive, establishing its substantial equivalence to a predicate device. It details the indications for use but does not include any performance data, study design, or acceptance criteria.
Therefore, I cannot populate the table or answer the specific questions about the study design, sample sizes, ground truth establishment, or expert involvement.
§ 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.