(99 days)
- Class III and V restorations o
- Restoration of minimally invasive cavity preparations (including small, non stress-bearing occlusal restorations)
- Base/liner under direct restorations .
- Repair of small defects in esthetic indirect restorations ●
- Pit and fissure sealant ●
- . Undercut blockout
- Repair of resin and acrylic temporary materials o
Nanova™ Flowable Dental Composite is a methacrylate based, low viscosity, visible-light activated, radiopaque, flowable composite. This device is available in syringe and ampule packaging. Nanova™ Flowable Dental Composite is available in a variety of tooth colored shades. Nanova™ Flowable Dental Composite contains methacrylate resins, photo-initiator, and inorganic filler material. Inorganic filler loading is approximately 60% by weight.
When irradiated by light, the methacrylate functionalities of the resins and surface-treated fillers undergo, in conjunction with the photo-initiator system, a light-induced polymerization to form a hard composite that is bonded to the tooth structure with a permanent dental adhesive.
Nanova™ Flowable Dental Composite formulation is based off of several FDA cleared commercially available flowable dental composites. The formulation was modified to improve physical properties, such as flexural strength, and handling properties. As a result of the reformulation, a biocompatibility assessment was developed for Nanova™ Flowable Dental Composite using standard risk assessment techniques and consideration of FDA & internationally recognized guidelines, including ISO 10993 Parts 3, 5, 6, 10 and 11.
The document describes the Nanova™ Flowable Dental Composite, a dental material. The acceptance criteria and supporting studies are detailed, primarily through comparison with a predicate device and non-clinical performance testing.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for "Nanova™ Flowable Dental Composite" are largely established by demonstrating its substantial equivalence to a legally marketed predicate device (Filtek Supreme Ultra Flowable Restorative K100235) and by meeting established international and ADA standards for dental materials.
| Acceptance Criteria (Standard / Predicate Comparison) | Reported Device Performance (Nanova™ Flowable Dental Composite) |
|---|---|
| Indications for Use: Same as predicate device. | Same as predicate device. |
| Composition: Methacrylate resins, photo-initiators, inorganic fillers. | Methacrylate resins, photo-initiators, inorganic fillers. |
| Flexural Strength: ISO 4049:2009 (E) | ISO 4049:2009 (E) (Passed / Met standard, comparison to predicate shows "Same") |
| Polymerization Method: Halogen and LED for 20s with minimum intensity 400 mW/cm² in the 400-500 nm range. | Halogen and LED for 20s with minimum intensity 400 mW/cm² in the 400-500 nm range. |
| Compressive Strength: ADA specification 27 | ADA specification 27 (Passed / Met standard, comparison to predicate shows "Same") |
| Shrinkage Stress: Indiana University School of Dentistry method. | Nanova less stress (Improved compared to predicate). |
| Depth of Cure: ISO 4049: 2009 (E) | Both Pass (Met standard, comparison to predicate shows "Both Pass") |
| Microtensile Strength: Internal Testing method. | Nanova Stronger (Improved compared to predicate). |
| Water Sorption: ISO 4049:2009 (E) | Nanova Less absorption (Improved compared to predicate). |
| Water Solubility: ISO 4049:2009 (E) | Same (Met standard, comparison to predicate shows "Same") |
| Packaging: Syringe and Ampule. | Syringe and Ampule. |
| Biocompatibility: ISO 10993 Parts 3, 5, 6, 10, 11 | Biocompatible based on assessment conducted. |
Specific quantitative values for performance (e.g., exact flexural strength in MPa) are not provided in this summary, but the document confirms that the device meets or exceeds the standards or predicate device performance for these properties.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for the individual non-clinical performance tests (e.g., number of specimens for flexural strength, depth of cure). It lists the types of tests performed.
The data provenance is from non-clinical benchtop testing performed by Nanova Biomaterials, Inc. and potentially external labs for GLP studies, but specific country of origin for all data is not explicitly stated. The submission is from Nanova Biomaterials, Inc. in Columbia, Missouri, USA. The studies are retrospective as they were conducted to support the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the studies are entirely non-clinical (benchtop and biocompatibility). There is no "ground truth" derived from expert consensus on patient data. The ground truth for performance is the specified standards (e.g., ISO, ADA) and comparison to the predicate device. For biocompatibility, it's defined by the ISO 10993 series.
4. Adjudication Method for the Test Set
This is not applicable as there is no human interpretation or subjective assessment of the test results that would require adjudication in the context of clinical or image-based studies. The results are quantitative measurements against established standards.
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
This is not applicable. The device is a dental restorative material, not an AI-powered diagnostic or assistive tool. No MRMC study was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical dental material, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for evaluating the Nanova™ Flowable Dental Composite is primarily:
- Established industry standards: ISO 4049:2009 (E) for properties like flexural strength, depth of cure, water sorption/solubility; ADA specification 27 for compressive strength.
- Comparison to a legally marketed predicate device: Filtek Supreme Ultra Flowable Restorative (K100235) for various technical and performance characteristics.
- Biocompatibility standards: ISO 10993 Parts 3, 5, 6, 10 and 11.
There is no pathology, outcomes data, or expert consensus on clinical cases described in this summary for establishing ground truth.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical material, not a machine learning model, therefore there is no "training set."
9. How the Ground Truth for the Training Set was Established
This is not applicable as there is no training set for this type of device.
§ 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.