(79 days)
Light Bond is intended for use as an orthodontic bracket adhesive.
Pad Lock® is intended for use as a fluorescing, light cure Orthodontic Bracket Adhesive.
Light Bond and Pad Lock are light cure, orthodontic bracket adhesives available in a variety of viscosities for bonding to metal, ceramic and composite surfaces. Both Light Bond and Pad Lock are available in fluoride and non-fluoride formulas and come in syringe style or tip dispensing.
In addition, Pad Lock fluoresces to ease clean-up of flash for the user.
The provided document is a 510(k) summary for orthodontic bracket adhesives (Light Bond™ and Pad Lock®). It is not a study report for an AI-powered device. Therefore, I cannot extract information about acceptance criteria or a study proving that an AI device meets acceptance criteria, as an AI device is not described in this document.
The document discusses the substantial equivalence of the Light Bond™ and Pad Lock® products to a predicate device (QUICK CURE, K001048), focusing on their intended use and mechanical/physical properties as orthodontic bracket adhesives.
§ 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.