(57 days)
For use in repairing, adding to, or otherwise modifying the surface of resins . Especially useful for enhancing co-polymentzation between an old and a new composite resin when the former requires refreshing or repair in clinical life. May also be used as the primer of indirect, resin-based restorations to enhance the bond of these with resin-based luting materials. This agent is also useful for bond of highly cross-inked denture teeth, acrylic or composite, to denture base resins, This material will improve the union between resin surfaces in a myriad of situations, both intra- and exta-orally.
A light-cured, resin-based primer that is used to enhance the bond of old to new resin-based materials. The material is indicated for use on the intaglio of indirect composite restorations. It can be used to refresh the worn but otherwise intact surfaces of composite resin restorations.
The provided text is a 510(k) summary for a dental resin primer, not an AI/ML device. Therefore, it does not contain information about studies proving the device meets acceptance criteria in the context of AI/ML, nor does it have details like sample sizes for test/training sets, expert qualifications, or MRMC studies.
The document describes a dental product "Comp. E" (a resin primer) and its intended use, along with a regulatory equivalence comparison to "Special Bond and Special Bond II". The FDA's letter states that the device is substantially equivalent to legally marketed predicate devices. This typically means that the device has similar technological characteristics and is intended for the same use as a predicate device that was on the market prior to May 28, 1976, or has been reclassified.
Without the specific type of device being an AI/ML product, the questions related to AI/ML acceptance criteria, study methodologies for AI/ML, and expert adjudication cannot be answered from the provided text.
§ 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.