(26 days)
The 3MM 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. 3MM Dent System is substantially equivalent to One Step™ Universal in terms of indications.
a simple adhesive system that offers the dental practitioner a wide range of applications. The 3MM 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. 3MM 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 3MTM Dent System, Prime & Bond™ and One Step™ Universal all utilize a resin that is intended to function as both primer and adhesive.
This document is a 510(k) summary for a dental adhesive system (3M™ Dent System resin tooth bonding agent system). It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain the type of information typically associated with evaluating a device's performance against specific acceptance criteria using a study with detailed statistical outcomes, ground truth, or expert review for diagnostic AI/imaging devices.
Therefore, I cannot fulfill your request to describe acceptance criteria and study details based on the provided text.
Here's why and what kind of information would be needed:
- Type of Device: The 3M™ Dent System is a resin tooth bonding agent, a dental material. Your request implies a diagnostic device, particularly one involving AI, imaging, and human reader performance, which requires very different types of evaluations.
- Performance Metrics: For a dental adhesive, "performance" is typically measured by metrics like:
- Bond strength (to dentin, enamel, various dental materials)
- Dentin permeability
- Microleakage
- Biological safety
- Lack of AI/Diagnostic Study Elements: The summary makes no mention of:
- Acceptance criteria for diagnostic accuracy (e.g., sensitivity, specificity, AUC)
- Test sets, training sets, or data provenance
- Expert readers, ground truth establishment, or adjudication
- MRMC studies or standalone algorithm performance
- Sample sizes for anything other than potentially biological safety testing.
The provided text focuses on demonstrating "substantial equivalence" to predicate devices based on material properties and biological safety, not on diagnostic accuracy of an AI system.
To answer your questions for an AI/diagnostic device, the input document would need to contain information similar to what you would find in a clinical study report or a 510(k) submission for a software as a medical device (SaMD) product that performs diagnosis or detection.
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St. Paul. MN 55144-1000 612 733 3149
AUG 12 1996
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:
Address:
Phone: Fax: Date: Trade Name: Common Names:
Scott T. Erickson Regulatory Affairs Specialist 3M Dental Products Laboratory 3M Center, Building 260-2B-09 St. Paul, MN 55144-1000 (612) 736-9883 (612) 736-0990 July 16, 1996 3M™ Dent System resin tooth bonding agent system, resin-based dental adhesive system Classification Name: resin tooth bonding agent (21CFR872.3200)
Predicate devices:
3MTM Scotchbond™ Multi-Purpose Plus Dental Adhesive System (K942493) Prime & Bond™ Direct Composite Bonding Agent (K951864) One Step™ Universal Dental Adhesive System (K# unknown)
The 3MM Dent System is a simple adhesive system that offers the dental practitioner a wide range of applications. The 3MM 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. 3MM 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 3MTM 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 3MTM 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 3MM 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 3MTM Dent System does not raise any new safety concerns. Refer to precautionary language in the 3MTM Dent Instructions 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.