(263 days)
The subject devices are intended to serve for the fabrication of core build-ups. They are also intended to serve as a base cement to affix pins and posts. They may be used with any Bis-GMA compatible bonding agent.
The subject devices are dual-cure (auto and photo), nanofilled resin composite materials. They are stackable for easy setting, with no condensation, radio opaque and fluoride releasing. The subject devices are presented in an Automix syringe and a Cartridge used with a gun. Dentocore and Dentocore Body have the same intended use; the former possessing a relatively higher viscosity. This quality is a selection for practitioners choosing this type of material. The subject devices present numerous advantages, notably the following: Good compressive strength, Low polymerization shrinkage, Fluorure release, Very high radio opacity properties.
This 510(k) summary describes an Abbreviated 510(k) submission for a dental material, not an AI/ML medical device. Therefore, much of the requested information about device performance, study design, and ground truth establishment, which are specific to AI/ML device evaluations, is not applicable or available in this document.
However, I can extract the relevant information provided for this device based on the submission type and available details:
1. Table of Acceptance Criteria and Reported Device Performance
As this is an Abbreviated 510(k) for a dental material, the "acceptance criteria" are related to conformity with recognized standards and demonstrating non-inferiority to a predicate device. Performance is primarily reported in relation to these standards and general material properties.
| Acceptance Criteria / Standard | Reported Device Performance (Dentocore Body, Dentocore) |
|---|---|
| Cytotoxicity (ISO 7405:1997 and ISO 10993) | Non-cytotoxic |
| Material Properties (General) | Good compressive strength, Low polymerization shrinkage, Fluoride release, Very high radio opacity properties |
| Premarket Notification Guidance Conformity | Conforms to FDA's guidance document "Dental Composites - Premarket Notification, November 1998" |
| International Standard Conformity | Conforms to ISO 4049 - Dentistry - Polymer-based filling, restorative and luting materials |
| Equivalence to Predicate Device (JIXacore/Dual) | Substantially equivalent for indicated uses and technological characteristics. |
Study Information (as applicable to a dental material 510(k)):
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: The document mentions "in vitro Cytotoxicity assay" and general material characteristic testing. Specific sample sizes for these tests are not provided in this summary.
- Data Provenance: The studies were in-vitro (laboratory-based) as per the cytotoxicity assay and material property evaluations. The country of origin for the data is not specified, though the submitter is Itena Clinical from Paris, France. The studies are by definition prospective in the context of generating data for this specific submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / Not specified. For dental material testing (e.g., cytotoxicity, mechanical properties), "experts" are typically involved in designing and interpreting the scientific experiments, following established protocols. The concept of "ground truth" established by a panel of human experts is not relevant here as the performance metrics are objective physical or biological measurements.
4. Adjudication method for the test set
- Not applicable. Adjudication methods (like 2+1, 3+1) are for human rater discrepancies in diagnostic image interpretation or similar tasks. This is not relevant for in-vitro material testing.
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 a dental material, not an AI-assisted diagnostic device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or is applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a dental material, not an algorithm or software device.
7. The type of ground truth used
- For the cytotoxicity assay, the "ground truth" was established by standardized biological assay protocols (ISO 7405:1997 and ISO 10993) using a well-characterized mouse cell line (L929). The reaction of positive and negative controls validated the test.
- For other material properties (compressive strength, polymerization shrinkage, fluoride release, radio opacity), the "ground truth" is based on objective scientific measurements and adherence to recognized material testing standards (like ISO 4049).
8. The sample size for the training set
- Not applicable. There is no "training set" in the context of evaluating a dental material as it's not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for an AI/ML model, this question is not relevant.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.