(62 days)
RM Bond Adhesive product is indicated for orthodontic applications using an indirect bonding treatment technique.
The subject device is a light-cured resin adhesive in a methacrylate-based formulation; the light curing feature provides the clinician appropriate flexibility for bracket placement working-time considerations. Product is supplied as refills in a variety of delivery systems; multi-use bottle or syringe as well as a single dose delivery system.
This document is a 510(k) summary for a dental adhesive (RM Bond Adhesive) and does not contain the detailed study information typically found in a clinical trial report or a performance study. The provided text indicates that the device is substantially equivalent to a predicate device but does not include acceptance criteria, performance data, or study methodologies that would allow for a comprehensive answer to your questions.
Therefore, I cannot provide the requested table or detailed information on sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. The content is focused on regulatory submission for substantial equivalence, not on a detailed scientific or clinical study report.
§ 872.3750 Bracket adhesive resin and tooth conditioner.
(a)
Identification. A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.(b)
Classification. Class II.