(71 days)
Prime & Bond™ 2.1 Multipurpose Dentin/Enamel Bonding Agent is a one-component, no-mix visible light curable dental bonding agent that contains fluoride. A new accessory, Prime & Bond™ Self-Curing Activator, can be used with Prime & Bond" 2.1 Multipurpose Dentin/Enamel Bonding Agent, enabling the practitioner to use self-cure bonding techniques for the current Indications for Use of the Bonding Agent where a dual-cured adhesive may be desired. Also because of the self-cure capability, use of the Bonding Agent and Activator cogether allows adhesion of amalgam restorations to tooth structures, which is a NEW INDICATION FOR USE.
Prime & Bond™ 2.1 Multipurpose Dentin/Enamel Bonding Agent is a one-component, no-mix visible light curable dental bonding agent that contains fluoride. No changes have been made to Prime & Bond™ 2.1 Multipurpose Dentin/Enamel Bonding Agent in design, material, chemical composition or manufacturing process. A new accessory, Prime & Bond™ Self-Curing Activator, can be used with Prime & Bond" 2.1 Multipurpose Dentin/Enamel Bonding Agent, enabling the practitioner to use self-cure bonding techniques for the current Indications for Use of the Bonding Agent where a dual-cured adhesive may be desired. Prime & Bond™ Self-Curing Activator is an acetone/ethanol solution of an aromatic sulfinic acid salt. When applied in combination with Prime & Bond™ 2.1 Multipurpose Dentin/Enamel Bonding Agent, the Activator initiates a self-cure, free radical polymerization of the monomers and oligomers present in the Prime & Bond™ 2.1 Multipurpose Dentin/Enamel Bonding Agent.
This 510(k) submission describes a dental bonding agent and an activator. However, it does not contain the detailed information required to fulfill the request concerning acceptance criteria and the specifics of a study proving device performance on a test set. This document is a summary for a regulatory submission, not a detailed study report. It states that "performance data presented for the use of Prime & Bond® 2.1 Multipurpose Dentin/Enamel Bonding Agent with the Prime & Bond Self-Curing Activator" was included, but the actual performance data and study details are not provided in this 510(k) summary.
Therefore, I cannot provide the requested information from the given text. The provided text is a high-level summary for a 510(k) submission and lacks the specific details about studies, acceptance criteria, sample sizes, expert qualifications, or ground truth methodologies.
§ 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.