(38 days)
Resin Tooth Bonding Agent is used to facilitate the adhesive bonding of restorative/preventive dental materials to dental hard tissues as well as to other restorative materials.
Cosmedent Resin Tooth Bonding Agent is a dual-cure 4th generation resin tooth bonding agent based on an acetone solution of room temperature polymerizing dimethacrylates. The device consists of two bottles designated as Primer A and Primer B. Primer A can be used alone and light cured, or it can be mixed with Primer B whereupon the adhesive will self cure in a clinically appropriate amount of time. In either case, two coats of the adhesive are applied to the prepared teeth. The adhesive bond strength of the device is approximately 25 MPa. The product is intended to be used to promote the adhesion of resin composite restoratives to dentin and enamel.
This device, Cosmedent Resin Tooth Bonding Agent, is a dual-cure 4th generation resin tooth bonding agent. The provided text indicates it's a 510(k) submission, meaning the manufacturer is demonstrating that their new device is substantially equivalent to a legally marketed predicate device. This type of submission relies on comparison to a predicate device rather than extensive new clinical trials to establish safety and effectiveness. Therefore, the information typically found in a clinical study report proving acceptance criteria is not present in this document.
However, based on the provided text, we can infer some "acceptance criteria" through the comparison made to the predicate device, Bisco All-Bond 2 (K910860). The primary performance metric mentioned for both the applicant and predicate device is adhesive bond strength.
Here's the breakdown of the information requested, based on the available text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Predicate) | Reported Device Performance (Applicant Device) |
|---|---|
| Adhesive bond strength of approximately 28 MPa (Predicate: Bisco All-Bond 2) | Adhesive bond strength of approximately 25 MPa |
Note: The "acceptance criteria" here are inferred from the performance of the legally marketed predicate device. For a 510(k), substantial equivalence implies that the new device's performance should be comparable to or not worse than the predicate's performance in clinically relevant aspects.
2. Sample size used for the test set and the data provenance
The document does not detail specific sample sizes for testing or data provenance for the reported bond strength values. 510(k) submissions often rely on bench testing and comparisons to predicate devices, rather than large-scale clinical trials. The reported bond strength values (25 MPa and 28 MPa) would typically come from in-vitro (bench) testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The document does not describe the establishment of a "ground truth" using experts for the reported bond strength. These values are typically derived from standardized material testing in a laboratory setting.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. The document does not describe an adjudication method as no expert-based review or clinical trial is detailed for the bond strength measurements.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, 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, a physical material, and does not involve AI or human "readers." Therefore, an MRMC study is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a dental bonding agent, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the reported bond strength is derived from physical/material testing (e.g., tensile or shear bond strength tests) typically conducted in a laboratory setting according to recognized standards (e.g., ISO standards for dental materials).
8. The sample size for the training set
Not applicable. As a material device, there is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" for this 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.