← Product Code [KLE](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE) · K964525 # PRIME & BOND 2.1 M.P. DENTIN/ENAMEL BONDING AGENT W/ACTIVATOR (K964525) _Dentsply Intl. · KLE · Jan 22, 1997 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K964525 ## Device Facts - **Applicant:** Dentsply Intl. - **Product Code:** [KLE](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE.md) - **Decision Date:** Jan 22, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3200 - **Device Class:** Class 2 - **Review Panel:** Dental ## Intended 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. 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 together allows adhesion of amalgam restorations to tooth structures, which is a NEW INDICATION FOR USE. ## Device Story One-component, no-mix visible light curable dental bonding agent containing fluoride; used with new Prime & Bond™ Self-Curing Activator (acetone/ethanol solution of aromatic sulfinic acid salt). Activator initiates self-cure free radical polymerization of monomers/oligomers in bonding agent. Used by dental practitioners in clinical settings. Enables dual-cured adhesive techniques and bonding of amalgam restorations to tooth structures. Benefits include expanded clinical utility for self-cure applications and improved restorative adhesion. ## Clinical Evidence Bench testing only; includes performance data for the bonding agent/activator combination and cytotoxicity test results for the activator's active ingredient. ## Technological Characteristics One-component, no-mix visible light curable resin bonding agent; contains fluoride. Activator is an acetone/ethanol solution of an aromatic sulfinic acid salt. Initiates free radical polymerization. ## Regulatory 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. ## Predicate Devices - Scotchbond M.P. Plus Dental Adhesive System ([K942493](/device/K942493.md)) - Prime & Bond™ 2.1 Multipurpose Dentin/Enamel Bonding Agent ([K962348](/device/K962348.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} JAN 22 1997 510(k) SUMMARY K964525 Page 1 of 2 DENTSPLY NAME & ADDRESS: DENTSPLY International 570 West College Avenue P.O. Box 872 York, PA 17405-0872 (717) 845-7511 Fax (717) 854-2343 P. J. Lehn Telefax (717) 849-6343 CONTACT: P. Jeffery Lehn DATE PREPARED: November 11, 1996 TRADE NAME: PRIME & BOND™ 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT WITH ACTIVATOR COMMON OR USUAL NAME: Bonding agent CLASSIFICATION NAME: Resin tooth bonding agent 21 CFR, 872.3200 PREDICATE DEVICES: Scotchbond M.P. Plus Dental Adhesive System K942493 Prime & Bond™ 2.1 Multipurpose Dentin/Enamel Bonding Agent K962348 DESCRIPTION AND INTENDED 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. Also because of the self-cure capability, use of the Bonding Agent and Activator together allows adhesion of amalgam restorations to tooth structures, which is a NEW INDICATION FOR USE. 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. {1} 510(k) SUMMARY (cont'd.) Page 2 of 2 # 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-Curing 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. --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K964525](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K964525) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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