(30 days)
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).
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.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the DENTSPLY PRIME & BOND™ 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT:
This document is a 510(k) summary for a dental bonding agent, focusing on demonstrating substantial equivalence to predicate devices rather than proving performance against specific quantitative acceptance criteria in a standalone study. Therefore, many of the requested categories, especially those related to AI algorithm performance, ground truth, and reader studies, are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (from predicate device performance) | Reported Device Performance (PRIME & BOND™ 2.1) |
|---|---|---|
| Direct Composite Bond Strength (Dentin) | Comparable to Prime & Bond™ 2.0 (K960823) | Comparable to Prime & Bond™ 2.0 |
| Direct Composite Bond Strength (Enamel) | Comparable to Prime & Bond™ 2.0 (K960823) | Comparable to Prime & Bond™ 2.0 |
| Direct Composite Bond Strength (Adhesive Repair) | Comparable to Prime & Bond™ 2.0 (K960823) | Comparable to Prime & Bond™ 2.0 |
| Indirect Composite Bond Strength (Metal Appliances) | Comparable to Prime & Bond™ 2.0 (K960823) | Comparable to Prime & Bond™ 2.0 |
| Indirect Composite Bond Strength (Inlays) | Comparable to Prime & Bond™ 2.0 (K960823) | Comparable to Prime & Bond™ 2.0 |
| Indirect Composite Bond Strength (Veneers) | Comparable to Prime & Bond™ 2.0 (K960823) | Comparable to Prime & Bond™ 2.0 |
| Microleakage Values | Comparable to Prime & Bond™ 2.0 (K960823) | Comparable to Prime & Bond™ 2.0 |
| Marginal Integrity | Not explicitly stated as a separate criterion, but predicate implies good performance | High degree |
| Incidence of Post Operative Hypersensitivity | Not explicitly stated as a separate criterion, but predicate implies low incidence | Reduced |
| Cytotoxicity | Non-cytotoxic (as per predicate devices) | Believed to be non-cytotoxic (due to similarity and prior testing) |
| Irritation | Non-irritant (as per predicate devices) | Believed to be non-irritant (due to similarity and prior testing) |
Notes on Acceptance Criteria: The primary "acceptance criteria" here are based on the concept of substantial equivalence to the predicate device, Prime & Bond™ 2.0 (K960823). The claim is that PRIME & BOND™ 2.1 performs comparably to the predicate device in key performance areas. There are no explicit numerical thresholds for these criteria provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a "test set" in the context of an AI algorithm or diagnostic device. The performance data mentioned (bond strength, microleakage) likely comes from laboratory testing on dental materials.
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified, but generally, dental material testing is conducted in a laboratory setting. It is not described as retrospective or prospective data from human patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This document does not describe a study involving human experts establishing ground truth for a diagnostic test set.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of adjudication for a test set in this context.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This device is a dental bonding agent, not an AI-powered diagnostic tool, and therefore no MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is a physical dental material, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" here is the established performance characteristics of the predicate device (Prime & Bond™ 2.0). The study aims to show that the new device's performance aligns with these established characteristics through experimental testing (e.g., measuring bond strength, microleakage).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
§ 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.