(115 days)
- Direct, light cured composite and compomer restorations.
- Light cured resin cemented veneers.
- Composite, ceramic and amalgam repairs.
- Cavity varnish for use with fresh amalgam.
- Indirect restorations and endodontic posts cemented with Calibra® Ceram.
- Desensitization of exposed dentin.
- Surface treatment of zirconia, metal, and composite.
In combination with DENTSPLY Self Cure Activator: - Direct dual cure / self-cure composite restorations and core build-ups.
- Cementation of indirect restorations and endodontic posts using dual cure / self-cure resin cements.
Prime&Bond active™ Universal Adhesive is a (meth) acrylate-based material which functions as a combined etch-and-rinse (Total-Etch), selfetch and selective-etch dental adhesive. It offers a simple adhesive application technique for both direct and indirect indications and bonds to enamel, dentin, composites, zirconia, and metals. When used with DENTSPLY Self Cure Activator, Prime&Bond active™ Universal Adhesive is compatible with dual cure / self-cure resin cements, composites and core build-ups materials. Prime&Bond active™ universal adhesive offers operators the choice of enamel and dentin pre-treatment: Self-etch mode: no phosphoric acid etching prior to application; Selective enamel-etch mode: selective phosphoric acid etching of enamel; Etch-and-rinse mode: phosphoric acid etching of both enamel and dentin.
The provided text describes the regulatory clearance for the "Prime&Bond active™ Universal Adhesive" and focuses on demonstrating substantial equivalence to a predicate device. This document does NOT contain information about a study proving the device meets specific acceptance criteria in the context of AI/ML device performance (e.g., accuracy, sensitivity, specificity, or human-in-the-loop improvement).
The document is a 510(k) summary for a dental adhesive, which is a physical material, not an AI/ML software device. Therefore, the questions related to AI/ML device performance metrics, sample sizes for test/training sets, ground truth establishment, expert adjudication, and MRMC studies are not applicable to the content provided.
However, I can extract information regarding the non-clinical performance data that was submitted to demonstrate substantial equivalence, which serves as the "study that proves the device meets the acceptance criteria" in this context.
Here's a breakdown based on the information provided, reinterpreting "acceptance criteria" and "study" to fit the type of device and submission:
1. Table of Acceptance Criteria and Reported Device Performance:
The document generally states that the device "satisfactorily met the requirements" of the non-clinical bench testing. Specific acceptance criteria are not numerically detailed in the given text; they are referenced as "requirements" of internal methods or ISO standards. However, the types of tests performed indicate the areas where performance was evaluated.
| Acceptance Criteria Category (Measured Property) | Reported Device Performance (General) |
|---|---|
| Physical Properties | |
| pH measurement | Satisfactorily met requirements (according to internal method). |
| Density measurement | Satisfactorily met requirements (according to internal method). |
| Film thickness measurement | Satisfactorily met requirements (according to internal method). |
| Shear Bond Strength (enamel & dentin - direct) | Satisfactorily met requirements (according to ISO 29022 "Dentistry – Adhesion – Notched edge shear bond strength test"). The document implies the results were comparable to the predicate device to establish substantial equivalence, though specific numerical results are not provided in this summary. |
| Shear Bond Strength (enamel & dentin - indirect) | Satisfactorily met requirements (according to internal test method). |
| Shear Bond Strength (Zirconia, Base Metal, Noble Metal, Composite - indirect) | Satisfactorily met requirements (according to internal test method). |
| Biocompatibility | |
| Cytotoxicity | Results supported substantial equivalence (in compliance with EN ISO 10993-1). |
| Chemical Analysis (leachable compounds) | Results supported substantial equivalence (in compliance with EN ISO 10993-1). |
2. Sample size(s) used for the test set and the data provenance:
- Sample Size: Not specified in the provided text for any of the bench tests.
- Data Provenance: The tests are described as "in vitro bench tests" and "non-clinical bench testing." The location and retrospective/prospective nature are not stated, but "in vitro" implies laboratory-based testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a material-based device, not an AI/ML diagnostic tool requiring expert ground truth for imaging or similar data. The "ground truth" for these tests would be the measured physical and chemical properties themselves, verified by standard laboratory procedures.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable, as this is not an AI/ML diagnostic device requiring adjudication of expert interpretations.
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:
- No. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the physical properties tests: The "ground truth" is established by the methods themselves (e.g., pH meter readings, density measurements, force gauges for shear bond strength) against pre-defined internal or ISO standard specifications.
- For biocompatibility: Ground truth is established by the results of standardized biological assays (e.g., cell viability in cytotoxicity tests, chemical identification and quantification in leachable studies) against allowable limits set by standards like EN ISO 10993-1.
8. The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the context of AI/ML.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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.