(105 days)
When used with the CLEARFIL BONDING SYSTEM, the product is indicated for the following uses.
[1] Core build-up in conjunction with self- or dual- cured core build-up materials
[2] Cementation in conjunction with self- or dual- cured composite resin cements
The subject device activates the dual-curing mechanism of the CLEARFIL BONDING SYSTEM (c.g. CLEARFIL SE BOND 2 or CLEARFIL SE Protect). The product is mixed with the BOND and can be used with dual-cure or self-cure composite filling materials, cements, or core build-up materials.
This document describes the CLEARFIL DC Activator, a dental product designed to activate the dual-curing mechanism of the CLEARFIL BONDING SYSTEM. The submission is a 510(k) summary, aiming to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance | Study Type |
|---|---|---|
| Tensile Bond Strength to Bovine Enamel: Not significantly different or not less than the predicate device. | "each tensile bond strength of the subject device to bovine enamel...was not significantly different or not less than that of the predicate device." | Comparison study against predicate device |
| Tensile Bond Strength to Bovine Dentin: Not significantly different or not less than the predicate device. | "each tensile bond strength of the subject device to bovine dentin was not significantly different or not less than that of the predicate device." | Comparison study against predicate device |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for the tensile bond strength tests on bovine enamel and dentin. However, it indicates that comparisons were made to a predicate device.
The provenance of the data is not specifically mentioned regarding country of origin or whether it was retrospective or prospective. Given the nature of a 510(k) submission for a dental product, it is most likely laboratory-based testing conducted by the manufacturer, which would be prospective in nature.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is a chemical activator for a bonding system, and its performance is evaluated based on objective physical properties (tensile bond strength), not subjective interpretation by experts. Ground truth in this context is established by the results of the physical tests themselves.
4. Adjudication Method for the Test Set
Not applicable. The evaluation relies on quantitative measurements (tensile bond strength), not on expert consensus or adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically relevant for interpretative devices where human readers assess outputs (e.g., medical imaging). This device is a chemical product, and its performance is assessed through physical property testing.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)
Yes, a standalone performance assessment was done. The "device" in this context is the CLEARFIL DC Activator itself, and its performance (tensile bond strength) was measured directly. There is no "human-in-the-loop" aspect to its function or evaluation, as it is a chemical component.
7. Type of Ground Truth Used
The ground truth used was objective physical measurements (tensile bond strength) obtained from laboratory testing. The comparison was made against the performance of a predicate device, establishing statistical equivalence or non-inferiority.
8. Sample Size for the Training Set
Not applicable. This device does not involve machine learning or AI, and therefore, there is no "training set." The performance is determined through experimental testing, not through model training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as 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.