← Product Code [KLE](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE) · K962348 # PRIME & BOND 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT (K962348) _Dentsply Intl. · KLE · Jul 18, 1996 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K962348 ## Device Facts - **Applicant:** Dentsply Intl. - **Product Code:** [KLE](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE.md) - **Decision Date:** Jul 18, 1996 - **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 self-priming bonding agent for use in direct and indirect restorative procedures, for adhesive repairs of amalgams, porcelain/metal and composite, and for an adhesive cavity varnish. ## Device Story One-component, no-mix, visible light-curing dental bonding agent; releases fluoride. Applied to prepared tooth surface; left for 20 seconds; air-dried; light-cured for 10 seconds. Used by dentists in clinical settings for restorative procedures and repairs. Enhances bond strength between tooth structure and restorative materials; provides marginal integrity; reduces post-operative hypersensitivity. ## Clinical Evidence Bench testing only. Performance data provided for direct/indirect composite bond strength and microleakage values, demonstrating comparability to predicate device K960823. ## Technological Characteristics One-component, light-cured resin bonding agent. Composition: monomers, fluoride, adhesion promoter, acetone solvent, photo-initiators, accelerators, polymerization inhibitors. Polymerization via visible light energy. Shelf-stable formulation. ## 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 - Prime & Bond™ 2.0 Multipurpose Dentin/Enamel Bonding Agent ([K960823](/device/K960823.md)) - Fluoride-PSA Prime/Adhesive ([K941572](/device/K941572.md)) - Prime & Bond Direct Composite Bonding Agent ([K931812](/device/K931812.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} K960348 510(k) SUMMARY 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) 849-4343 JUL 18 1996 CONTACT: P. Jeffery Lehn DATE PREPARED: June 17, 1996 TRADE NAME: PRIME & BOND™ 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT COMMON OR USUAL NAME: Bonding agent CLASSIFICATION NAME: Resin tooth bonding agent 21 CFR, 872.3200 PREDICATE DEVICES: Prime & Bond™ 2.0 Multipurpose Dentin/Enamel Bonding Agent K960823 Fluoride-PSA Prime/Adhesive K941572 Prime & Bond Direct Composite Bonding Agent K931812 DEVICE DESCRIPTION: PRIME & BOND™ 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT is a one-component, no-mix, visible light curing dental bonding agent that releases fluoride. The new bonding agent consists of a mixture of monomers, fluoride, and an adhesion promoter in an acetone solution. Additionally, the mixture contains photo-initiators, accelerators and polymerization inhibitors which allow for a shelf stable material that can be polymerized using visible light energy. Once the tooth to be restored has been prepared, PRIME & BOND™ 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT is applied, left on the surface for 20 seconds, air dried, and then light cured for 10 seconds. A second application may be applied for direct restorative procedures, but this is not required for indirect procedures. PRIME & BOND™ 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT and Prime & Bond™ 2.0 Multipurpose Dentin/Enamel Bonding Agent (K960823) are comparable in direct composite bond strength (dentin, enamel, adhesive repair), indirect composite bond strength (metal appliances, inlays, onlays, veneers), and microleakage values. PRIME & BOND™ 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT has a high degree of marginal integrity and a reduced incidence of post operative hypersensitivity. INTENDED USE: PRIME & BOND™ 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT is a self-priming bonding agent for use in direct and indirect restorative procedures, for adhesive repairs of amalgams, porcelain/metal and composite, and for an adhesive cavity varnish. The intended uses of PRIME & BOND™ 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT are identical to the intended uses of Prime & Bond™ 2.0 Multipurpose Dentin/Enamel Bonding Agent (K960823). 000014 {1} 510(k) SUMMARY (cont'd.) Page 2 of 2 TRADE NAME: PRIME & BOND™ 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT TECHNOLOGICAL CHARACTERISTICS: All of the components of PRIME & BOND™ 2.1 SELF-PRIMING DENTIN/ENAMEL BONDING AGENT have been used in the DENTSPLY predicate devices, Prime & Bond™ 2.0 Multipurpose Dentin/Enamel Bonding Agent (K960823) and Fluoride-PSA Prime/Adhesive (K941572). These devices were evaluated for cytotoxicity and for irritation and found to be non-cytotoxic and a non-irritant. Due to the similarity of the new formulation to the primary predicate device (K960823), we believe that additional toxicity testing for PRIME & BOND™ 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT is unnecessary. We believe that the prior use of the PRIME & BOND™ 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT components in predicate devices, the near identical formulation to the predicate device, the performance data and fluoride release data presented, and the results of toxicity testing on predicate devices, support the safety and effectiveness of PRIME & BOND™ 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT for the intended uses. 000015 --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K962348](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K962348) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com