← Product Code [KLE](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE) · K962785 # 3M DENT SYSTEM (K962785) _3M Company · KLE · Aug 12, 1996 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K962785 ## Device Facts - **Applicant:** 3M Company - **Product Code:** [KLE](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE.md) - **Decision Date:** Aug 12, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3200 - **Device Class:** Class 2 - **Review Panel:** Dental - **Attributes:** Therapeutic ## Intended Use The 3M™ Dent System is intended to be used as a 21 CFR 872.3200 resin tooth bonding agent. ## Device Story 3M™ Dent System is a resin-based dental adhesive system; used by dental practitioners for tooth bonding. System utilizes phosphoric acid etchant and methacrylate resin; polymerizes upon exposure to visible light from dental light curing unit. Resin functions as both primer and adhesive. Applied in clinical dental settings to bond restorative materials to dentin and enamel. Benefits include improved adhesion and reduced microleakage in dental restorations. ## Clinical Evidence Bench testing only. Performance data includes bond strength to dentin, enamel, and dental materials; dentin permeability; and microleakage. Biological safety assessment conducted per ISO-10993. ## Technological Characteristics Resin-based dental adhesive system. Components: phosphoric acid etchant and methacrylate resin. Polymerization via visible light curing unit. Complies with ISO-10993 for biological safety. ## 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 - 3M™ Scotchbond™ Multi-Purpose Plus Dental Adhesive System ([K942493](/device/K942493.md)) - Prime & Bond™ Direct Composite Bonding Agent ([K951864](/device/K951864.md)) - One Step™ Universal Dental Adhesive System (K# unknown) ## 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} St. Paul, MN 55144-1000 612 733 3149 AUG 12 1996 K962785 510(K) SUMMARY This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92. Name: Scott T. Erickson Regulatory Affairs Specialist Address: 3M Dental Products Laboratory 3M Center, Building 260-2B-09 St. Paul, MN 55144-1000 Phone: (612) 736-9883 Fax: (612) 736-0990 Date: July 16, 1996 Trade Name: 3M™ Dent System Common Names: resin tooth bonding agent system, resin-based dental adhesive system Classification Name: resin tooth bonding agent (21CFR872.3200) Predicate devices: 3M™ Scotchbond™ Multi-Purpose Plus Dental Adhesive System (K942493) Prime & Bond™ Direct Composite Bonding Agent (K951864) One Step™ Universal Dental Adhesive System (K# unknown) The 3M™ Dent System is a simple adhesive system that offers the dental practitioner a wide range of applications. The 3M™ Dent System is substantially equivalent to the predicate devices above in that all are intended to be used as a 21 CFR 872.3200 resin tooth bonding agent. 3M™ Dent System is substantially equivalent to One Step™ Universal in terms of indications. The design of the 3M™ Dent System is substantially equivalent to the predicate devices above because all utilize a phosphoric acid etchant and a methacrylate resin that will polymerize upon exposure to visible light from a dental light curing unit. The 3M™ Dent System, Prime & Bond™ and One Step™ Universal all utilize a resin that is intended to function as both primer and adhesive. The performance of the 3M™ Dent System is substantially equivalent to the predicate devices above, based on nonclinical performance data including bond strength to dentin, enamel and various dental materials, dentin permeability and microleakage. Biological safety assessment, conducted in accordance with ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing (with FDA modified matrix), does not raise any new safety concerns and indicates that 3M™ Dent Resin is safe for its intended use. The phosphoric acid etchant component of the 3M™ Dent System has already been legally marketed globally for several years with another 3M dental adhesive system. Use of this phosphoric acid etchant as part of the 3M™ Dent System does not raise any new safety concerns. Refer to precautionary language in the 3M™ Dent Instructions for Use. --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K962785](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K962785) **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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