(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.
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JAN 22 1997
510(k) SUMMARY
DENTSPLY
NAME & ADDRESS :
849-6363 P. J. Lehn Telefax
P. Jeffery Lehn CONTACT :
November 11. 1996 DATE PREPARED:
PRIME & BOND™ 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT TRADE NAME: WITH ACTIVATOR
Bonding agent COMMON OR USUAL NAME:
21 CFR, 872.3200 Resin tooth bonding agent CLASSIFICATION NAME:
PREDICATE DEVICES: Scotchbond M.P. Plus Dental Adhesive System K942493 K962348 Prime & Bond™ 2.1 Multipurpose Dentin/Enamel Bonding Agent
Prime & Bond™ 2.1 Multipurpose Dentin/Enamel DESCRIPTION AND INTENDED USE: 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.
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.
& Bond™ Self-Curing Activator is an acetone/ethanol solution of an Prime 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.
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510(k) SUMMARY (cont'd.)
TRADE NAME: PRIME & BOND™ 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT WITH ACTIVATOR
TECHNOLOGICAL CHARACTERISTICS: No changes have been made to Prime & Bond™ 2.1 Multipurpose Dentin/Enamel Bonding Agent in design, material, chemical composition or manufacturing process.
All of the components of the Prime & Bond® Self-Curing Activator have been used in legally marketed devices or have been proven to be safe for dental use.
We believe the fact that Prime & Bond® 2.1 Multipurpose Dentin/Enamel Bonding Agent has not been changed, the prior use of the Prime & Bond™ Self-Guring Activator components in predicate devices, the performance data presented for the use of Prime & Bond® 2.1 Multipurpose Dentin/Enamel Bonding Agent with the Prime & Bond Self-Curing Activator, and the cytotoxicity test results of the Activator active ingredient support the safety and effectiveness of Prime & Bond® 2.1 Multipurpose Dentin/Enamel Bonding Agent when used with Prime & Bond® Self-Curing Activator for the new indications for use.
§ 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.