(111 days)
Nanova 2 Step Etch and Rinse Dental Adhesive is indicated for use in:
- All direct restorations
- All indirect restorations
- Intra-oral repairs
- Desensitizing/sealing of tooth structure
- Priming of enamel for orthodontic use
Nanova™ 2 Step Etch and Rinse Dental Adhesive is a methacrylate based, visible-light activated, dental adhesive, the same as the predicate. This device is available in bottle or unit dose packaging, the same as the predicate. Nanova™ 2 Step Etch and Rinse Dental Adhesive contains ethanol, methacrylate resins, photoinitiator, and inorganic filler material the same as the predicate.
When irradiated by light, the methacrylate functionalities of the resins and surface-treated fillers undergo, in conjunction with the photoinitiator system, a light-induced polymerization to form a hard sealant that is bonded to the prepared tooth structure.
The provided text describes the 510(k) summary for the "Nanova 2 Step Etch and Rinse Dental Adhesive". It focuses on establishing substantial equivalence to a predicate device through non-clinical performance testing and biocompatibility assessment, and explicitly states that no clinical performance data was conducted.
Therefore, the study design elements related to clinical trials, human reader performance, ground truth establishment for clinical data, or expert adjudication are not applicable to this submission.
Here's the breakdown of the information available in the document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Property | Standard | Acceptance Criteria (Internal Performance Criteria) | Reported Device Performance |
|---|---|---|---|
| Shear Bond Strength | ISO 29022:2013 | Met internal performance criteria | Met internal performance criteria |
| Micro-Tensile Strength | Internal specifications | Met internal performance criteria | Met internal performance criteria |
| Water Sorption | ISO 4049:2009 | Met internal performance criteria | Met internal performance criteria |
| Water Solubility | ISO 4049:2009 | Met internal performance criteria | Met internal performance criteria |
| Degree of Conversion | Internal specification | Met internal performance criteria | Met internal performance criteria |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified. The document states "non-clinical performance testing conducted is shown in the table below," but does not provide specific sample sizes for each test.
- Data provenance: Not explicitly stated, but it refers to "non-clinical performance testing," implying laboratory-based testing rather than patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. No clinical test set or human-in-the-loop performance evaluation was conducted. Ground truth for non-clinical tests is established by laboratory measurements and adherence to specified standards.
4. Adjudication method for the test set:
- Not Applicable. No clinical test set or human adjudication was involved.
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. No MRMC study was performed as no clinical performance data was conducted. The device is a dental adhesive, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable (in the context of AI/algorithm performance). This device is a biomaterial (dental adhesive), not an algorithm. The non-clinical performance tests are standalone evaluations of the material's physical and mechanical properties.
7. The type of ground truth used:
- For non-clinical performance tests, the "ground truth" is based on established material testing standards (ISO 29022:2013, ISO 4049:2009) and internal specifications. These standards define the methodologies and expected outcomes for measuring the specific properties (e.g., bond strength, water sorption).
8. The sample size for the training set:
- Not Applicable. There is no "training set" as this is not an AI/machine learning device.
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.