(70 days)
Sil-Flow is indicated for
[A] Temporary inlay and onlay treatments of the cavity
[B] Sealing of openings for implant screws
[C] Relining material for temporary crowns and bridges
[D] Block-out material for retentive areas in the dental arch, e.g. before taking impressions
[E] Covering of the gingival margin
[F] Fixing of resin matrix during filling placement
[G] Temporary filling of cavities
Sil-Flow is a flowable light-cured temporary filling material used for filling and sealing.
The provided FDA Premarket Notification (510(k)) for the Sil-Flow device is for a Tooth Shade Resin Material and NOT an AI/Software as a Medical Device (SaMD) product. Therefore, the information typically found in such a submission regarding AI device performance, such as:
- Acceptance Criteria for AI performance metrics (e.g., sensitivity, specificity, AUC)
- Study design for AI performance evaluation (e.g., standalone, human-in-the-loop, MRMC)
- Sample size and data provenance for AI test sets
- Ground truth establishment (number/qualifications of experts, adjudication methods)
- Training set details for AI models
- Effect size of AI assistance for human readers
are not present in this document.
This 510(k) submission focuses on demonstrating substantial equivalence to a predicate device (Clip Flow) based on physical and chemical properties, biocompatibility, and intended use for a dental material.
Here's a breakdown of the requested information based on the provided document, highlighting what is present and what is absent from the perspective of an AI/SaMD device:
Acceptance Criteria and Study Proving Device Meets Criteria (for Dental Material)
The acceptance criteria and supporting study for Sil-Flow relate to its physical, chemical, and biological properties as a tooth shade resin material, demonstrating its safety and performance for its indicated uses.
1. A table of acceptance criteria and the reported device performance
| Test Parameter | Acceptance Criteria (from ISO 4049 Protocol) | Reported Device Performance | Comments |
|---|---|---|---|
| Physical/Chemical Properties | |||
| Visual Appearance | (Implied to meet standard) | Met criteria | "All test results met the criteria in the standard." |
| Depth of Cure (mm) | Not explicitly stated (but referenced ISO 4049) | 3.1 mm | Predicate device (Clip Flow) reported 11mm, suggesting a difference. However, "Both the subject devices and the predicate device have physical parameters which meet the requirements of the relevant ISO standards," implying 3.1mm is acceptable per the standard for Sil-Flow. |
| Shor Hardness D | Not explicitly stated | 52 Shor D | Predicate (Clip Flow) reported 90 Shore A. Note the difference in Shore scale (D vs. A), making direct comparison difficult without a conversion or further context, but still stated to meet relevant ISO standard. |
| Sensitivity to Ambient Light | (Implied to meet standard) | Met criteria | "All test results met the criteria in the standard." |
| Water Sorption (µg/mm³) |
§ 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.