(18 days)
SURPASS™ is a universal adhesive system that when properly employed, can be used to seal enamel/dentin prior to restoring with light-cured composite materials. Also, in situations of indirect restorations, the bonding system can be used to seal a preparation when using a light-cured, self-cured or dual-cured composite cement or glass ionomer or resinmodified glass ionomer cement. In addition, the system allows the dentist to bond a post and core, along with the use to treat hypersensitive and/or exposed root surfaces.
Indications For Use:
- Restorations: to seal enamel/dentin prior to restoring with light-cured or self-cured composite materials.
- Indirect Restorations: to seal a preparation when using a light-cured, self-cured or dual-cured composite cement or glass ionomer or resin-modified glass ionomer cement.
- Desensitization: to treat hypersensitive and/or exposed root surfaces.
- To bond in a post and core.
SURPASS™ is a light cured (free radical polymerization), self-etching dental adhesive system. designed to provide a dentist with an increased ease of use that is less technique sensitive. The bonding system combines both the etchant and primer applications into one simple step followed by a thin layer of unfilled bonding resin. Thus, allowing for more predictable clinical results without sacrificing bond strength integrity.
SURPASS™ 2 is an ethanol-based adhesive that is dependent on the prepared surface of its conditioner (SURPASS™ 1). This acidic conditioner application is a procedure that is very similar to the phosphoric acid etching process of dentin/enamel substrate in the ECLIPTOMER (510K number K945604, Bisco, Inc.) system. Applying the SURPASS™ 2 (adhesive resin) directly to the conditioner prepared surface, assures proper moistness on the bonding interface, resulting in a reliable simplified bonding protocol. Once SURPASS™ 2 has been dried a thin layer of SURPASS™ 3 is applied to the SURPASS™ 2 surface and light cured for 20 seconds. The SURPASS™ 3 acts as a superior tie layer between SURPASS™2 and the filling material of choice.
Here's a breakdown of the acceptance criteria and study information for the SURPASS™ Dental Bonding Adhesive Resin, based on the provided document:
This document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific acceptance criteria in the manner one might find for a novel, high-risk device. The primary "acceptance criteria" here relate to the device's physical properties being comparable to its predicate.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | SURPASS™ is "substantially equivalent to ECLIPTOMER (510K number K945604, Bisco, Inc.)" based on physical testing observations and analysis, including shear bond strength to dentin and enamel, similar handling, same indication for use, and same base composition as Simplicity® Adhesive System (K020570). |
| Shear Bond Strength (to dentin and enamel) | "similar to" ECLIPTOMER |
| Similar Handling Characteristics | "similar handling to" ECLIPTOMER |
| Predictable Clinical Results without sacrificing bond strength integrity | Achieved through the design of a self-etching system that combines etchant and primer, followed by a thin layer of unfilled bonding resin. |
| Increased Ease of Use, less technique sensitive | Achieved through the design of a self-etching system that combines etchant and primer. |
| Long-time industry standards for individual components | Individual components of SURPASS™ are stated to be "long-time industry standards and are utilized in numerous dental bonding systems currently marketed in the United States." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the "physical testing observations and analysis, including shear bond strength to dentin and enamel." It only mentions that this testing was performed to support the substantial equivalence claim.
The data provenance is not specified beyond indicating it was performed by Apex Dental Materials, Inc. It's typical for such tests to be conducted in a laboratory setting, and the nature of the tests (physical properties) suggests a prospective experimental study rather than retrospective clinical data. The country of origin for the data is implicitly the United States, where the manufacturer is located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For physical property tests of dental bonding agents, "ground truth" is typically established through standardized laboratory measurement protocols and material science principles, rather than expert clinical consensus as might be seen for diagnostic imaging.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. Adjudication methods (like 2+1, 3+1) are relevant for studies involving human interpretation or clinical outcomes, which is not the primary focus of this submission. The evaluation is based on objective physical property measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is for evaluating human performance, often in diagnostic imaging, and is not relevant for the physical properties validation of a dental bonding agent.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable in the context of this device. A dental bonding adhesive is a material, not a "device" in the sense of a software algorithm or an automated diagnostic tool that would have a standalone performance.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation of the SURPASS™ device is based on objective measurements of physical properties, specifically focusing on shear bond strength to dentin and enamel. This is compared against the known properties of the predicate device (ECLIPTOMER).
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable here. This device is a material, not an AI/ML algorithm that requires a training set. The submission describes the development of the adhesive system, but not a data-driven model training process.
9. How the Ground Truth for the Training Set Was Established
As the concept of a training set is not applicable, this information is also not provided.
§ 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.