(26 days)
No
The description focuses on the chemical composition and function of a dental bonding agent, with no mention of AI or ML.
No.
The device is a bonding agent used in dental procedures, not a device that treats or prevents a disease or condition. Its function is to adhere materials to teeth.
No
This device is a resin tooth bonding agent, which is used for adhesive purposes in dentistry, not for diagnosing conditions or diseases.
No
The device description clearly indicates it is a physical adhesive system utilizing chemical components (phosphoric acid etchant, methacrylate resin) and requiring a physical dental light curing unit for polymerization. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "21 CFR 872.3200 resin tooth bonding agent." This regulation specifically covers dental devices used for bonding restorative materials to teeth.
- Device Description: The description details a "simple adhesive system" for dental practitioners, focusing on its chemical composition and how it functions in bonding to teeth.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose, monitor, or screen for any disease or condition. Its function is purely therapeutic/restorative.
- Performance Metrics: The performance studies focus on metrics relevant to dental bonding, such as bond strength, permeability, and microleakage, not diagnostic accuracy metrics like sensitivity or specificity.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes
Not Found
Device Description
The 3M™ Dent System is a simple adhesive system that offers the dental practitioner a wide range of applications. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental practitioner
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
3MTM Scotchbond™ Multi-Purpose Plus Dental Adhesive System (K942493), Prime & Bond™ Direct Composite Bonding Agent (K951864), One Step™ Universal Dental Adhesive System (K# unknown)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.