(63 days)
For use as a tooth-bonding agent that seals patent dentinal tubules to reduce hypersensitivity and aids in the retention of tooth-colored dental to reduce hypersenstering into are over EASY BOND that has been painted onto prepared cavities.
EASY BOND may be described as a single-bottle, light-cured, dentin bonding system especially formulated for use with resin composite restorative materials. It will also create reliable bonds properly prepared metallic surfaces that are free from contamination. EASY BOND is recommended on moist dentin substrates that have had any smear layer removed.
This document is a 510(k) summary for a dental bonding agent called "EASY BOND." It does not contain information about acceptance criteria, device performance, or a study proving that a device meets particular acceptance criteria, as it is a notice of intent to market a device and the FDA's response finding substantial equivalence.
Therefore, I cannot extract the requested information from the provided text. The document primarily focuses on regulatory classification, intended use, and the FDA's clearance for marketing based on substantial equivalence to existing devices, rather than detailed performance study results.
§ 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.