(322 days)
For use as a tooth shade resin material in dental procedures, such as:
- Direct anterior and posterior restorations
- Cavity lining
- Blocking out cavity undercuts before fabricating indirect restorations
- Repair of porcelain/composite
ESTELITE BULK FILL Flow is a low viscosity, light cured radiopaque composite dental tooth shade resin material. This low stress flowable material can be placed in 4 mm increments. The device incorporates Radical-Amplified Photopolymerization (RAP) initiator technology, which facilitates a shortened light curing time and ample working time. The device comes in five shades, namely U (Universal), A1, A2, A3, and B1.
This document describes the premarket notification (510(k)) for the Tokuyama Dental Corporation's "ESTELITE BULK FILL Flow tooth shade resin material." The FDA determined the device is substantially equivalent to legally marketed predicate devices.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document provides a table comparing the new device (ESTELITE BULK FILL Flow) to its primary predicate (ESTELITE FLOW QUICK) and references ISO 4049:2009 for many properties.
| Characteristic | Acceptance Criteria (Predicate/ISO 4049) | Reported Device Performance (ESTELITE BULK FILL Flow) |
|---|---|---|
| Sensitivity to Ambient Light | Material remained physically homogenous (A3) | Material remained physically homogenous (A3) |
| Conformed to ISO 4049 requirement | Conformed to ISO 4049 requirement | |
| Depth of Cure (mm) | 2.0 ± 0.1 (A3) | 4.0 ± 0.1 (Universal); 3.6 ± 0.1 (A3) |
| Conformed to ISO 4049 requirement | Conformed to ISO 4049 requirement | |
| Flexural Strength (MPa) | 152.5 ± 20.2 (A3) | 146 ± 4 (A3) |
| Water Sorption (µg/mm³) | 9.0 ± 0.1 (A3) | 22.5 ± 0.5 (A3) |
| Conformed to ISO 4049 requirement | Conformed to ISO 4049 requirement | |
| Solubility (µg/mm³) | 0.6 ± 0.2 (A3) | 0.6 ± 0.3 (A3) |
| Conformed to ISO 4049 requirement | Conformed to ISO 4049 requirement | |
| Shade | Matched shade guide (A3) | Matched shade guide (A3) |
| Conformed to ISO 4049 requirement | Conformed to ISO 4049 requirement | |
| Color Stability | Slight change in color observed (A3) | No more than a slight change in color observed (A3) |
| Conformed to ISO 4049 requirement | Conformed to ISO 4049 requirement | |
| Radio-opacity (mm of Al) | 1.2 (A3) | 1.7 (A3) |
| Conformed to ISO 4049 requirement | Conformed to ISO 4049 requirement | |
| Compressive Strength (MPa) | 375 ± 26 (A3) | 371 ± 10 (A3) |
| Elastic Modulus (GPa) | 8.8 ± 0.4 (A3) | 7.5 ± 0.1 (A3) |
| Surface Hardness (Hy) | 44 (A3) | 35 (A3) |
| Diametral Tensile Strength | Conformed to ISO 4049 requirement | Conformed to ISO 4049 requirement |
| Biocompatibility | All ingredients authorized by FDA for similar devices | All ingredients authorized by FDA for similar devices |
Note: The document explicitly states "Conformed to the requirement of ISO 4049" for several physical properties, implying these are the acceptance criteria and the device met them. For other properties, the predicate's performance serves as the benchmark for substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes used for the non-clinical physical property tests. It only states that the testing was "conducted in accordance with ISO 4049:2009," which would imply adherence to its specified sample sizes if applicable.
The provenance of the data is implied to be from Tokuyama Dental Corporation, which is based in Japan, as per the submitter information. The testing is non-clinical, so the retrospective/prospective distinction for human data is not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not applicable as the studies conducted were non-clinical, measuring physical properties of the material in a laboratory setting, not evaluating diagnostic performance with human judgment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable as there were no human expert judgments or adjudications involved in establishing the ground truth for the physical property tests.
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. An MRMC comparative effectiveness study was not done. The device is a dental material, not an AI-assisted diagnostic tool. The document states: "There were no clinical tests performed for the ESTELITE BULK FILL Flow device."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in a sense, a standalone assessment of the material's properties was performed by conducting non-clinical physical property tests. However, this is not a "standalone algorithm" in the context of AI. It refers to the intrinsic performance of the material itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance data of the device was established through laboratory measurements of physical properties according to published standards (ISO 4049:2009). For biocompatibility, the ground truth was based on prior FDA authorization of the device's ingredients in other similar devices and the historical absence of adverse events.
8. The sample size for the training set
This information is not applicable. The device is a dental material, not an AI/ML algorithm that requires a training set. The performance data presented are from testing the physical properties of the final product.
9. How the ground truth for the training set was established
This information is not applicable as there was no training set for an AI/ML algorithm.
§ 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.