(36 days)
R-30 AESTHETIC RESTORATIVE is to be used with Prime & Bond® NT™ Dental Adhesive System for cavity classes I, II, III, IV, V and VI in anterior and posterior teeth as a direct restorative material, anterior direct veneering material, and may be used for the fabrication of indirect inlays and onlays.
R-30 AESTHETIC RESTORATIVE is a visible light activated, radiopaque restorative material for anterior and posterior restorations of primary and permanent teeth. It is to be used with Prime & Bond® NT™ Dental Adhesive System. The material is a one-component, VLC composite restorative, packaged in syringes or compules.
The provided text describes a 510(k) premarket notification for a dental restorative material called R-30 AESTHETIC RESTORATIVE. It focuses on demonstrating substantial equivalence to a predicate device and meeting a recognized standard for physical properties.
Here's an analysis of the requested information based on the provided text:
Acceptance Criteria and Study Details for R-30 AESTHETIC RESTORATIVE
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical properties meet ISO Standard 4049. | "The physical properties of R-30 AESTHETIC RESTORATIVE meet ISO Standard 4049." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific "test set" sample size or data provenance (e.g., country of origin, retrospective/prospective). The claim is that the device meets the ISO standard, implying testing was performed, but details of that testing are not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
N/A. This type of information is not relevant or provided for a material's physical property testing against an ISO standard. There is no "ground truth" established by experts in the context of material specifications.
4. Adjudication Method for the Test Set
N/A. Adjudication methods are typically relevant for studies involving human interpretation or clinical outcomes, not for direct physical property testing of a material against a predefined standard.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A MRMC comparative effectiveness study is not relevant for this type of device (dental restorative material) and its associated claims (physical properties meeting an ISO standard, substantial equivalence). It would typically be used for diagnostic imaging devices or other tools where human interpretation plays a significant role.
6. Standalone (Algorithm Only) Performance Study
No. This concept is not applicable as the device is a physical dental restorative material, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" in this context is the ISO Standard 4049 physical property specifications. The device's performance is compared directly against the quantitative limits and requirements outlined in this international standard for dental polymer-based restorative materials.
8. Sample Size for the Training Set
N/A. This device is a physical material, not an AI/algorithm-based system. Therefore, there is no "training set" in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established
N/A. As there is no training set for a machine learning algorithm, this question is not applicable. The "ground truth" for the material's properties is the ISO standard itself.
Summary of Device Performance Study:
The primary study referenced, albeit briefly, is the testing conducted to ensure the R-30 AESTHETIC RESTORATIVE meets ISO Standard 4049. This standard specifies requirements for dental polymer-based restorative materials, covering properties such as flexural strength, depth of cure, water sorption, solubility, and other mechanical and physical characteristics.
The submission states, "The physical properties of R-30 AESTHETIC RESTORATIVE meet ISO Standard 4049." This statement serves as the core evidence of the device's technical performance. While the detailed test reports (sample sizes for specific tests, methodologies, raw data) are not included in this summary document, the FDA's clearance (K984387) indicates that sufficient evidence was provided at the time to support this claim and establish substantial equivalence for the intended uses. The substantial equivalence argument also heavily relies on the fact that the components of R-30 AESTHETIC RESTORATIVE were previously used in the predicate device (SureFil™ High Density Posterior Restorative K973221), supporting its safety and effectiveness.
§ 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.