(120 days)
Nanova Universal Dental Composite is indicated for use in:
- · Direct anterior and posterior restorations (including occlusal surfaces)
- Core Build-ups
- · Splinting
- · Indirect restorations including inlays, onlays and veneers
Nanova™ Universal Dental Composite is a methacrylate based, visible-light activated, radiopaque, universal composite. This device is available in twist syringe and ampule packaging. Nanova™ Universal Dental Composite is available in a variety of tooth colored shades. Nanova"™ Universal Dental Composite contains methacrylate resins, photo-initiator, and inorganic filler material. Inorganic filler loading is approximately 77% 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™ Universal Dental Composite formulation is based off of several FDA approved commercially available universal 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™ Universal Dental Composite using standard risk assessment techniques and consideration of FDA & International Standards, including ISO 10993 Parts 5 and 10.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
Acceptance Criteria and Device Performance
The document does not explicitly state numerical acceptance criteria with pass/fail thresholds for each test in a table format. Instead, it indicates that the device "Passed" each test, implying that it met the (unspecified) acceptance criteria for those tests. It also compares the device's performance to the predicate device in a qualitative manner for some properties.
| Acceptance Criteria (Implied) | Reported Device Performance (Nanova™ Universal Dental Composite) |
|---|---|
| Meets ISO 4049 requirements (Flexural Strength) | > 100 MPa (Consistent with predicate) |
| Meets ADA specification 27 (Compressive Strength) | > 300 MPa (Consistent with predicate) |
| Passes ISO 4049:2009(E) (Depth of Cure) | Passed |
| Meets ISO 4049:2009(E) (Water Sorption) | Less Adsorption (Compared to predicate) |
| Meets ISO 4049:2009(E) (Water Solubility) | Less Solubility (Compared to predicate) |
| Biocompatible (ISO 10993 Parts 5 and 10) | Passed all biocompatibility tests (Cytotoxicity, irritation, sensitization) |
| Radiopacity Evaluation | Passed |
| Color Stability | Passed |
| Microtensile Strength | Passed |
| Knoop Hardness | Passed |
| Double Bond Conversion (Degree of Conversion) | Passed |
| Shelf life | Passed |
| Surface Gloss | Passed |
| Surface Roughness | Passed |
Study Details
The provided document describes a non-clinical performance testing study.
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Sample size used for the test set and the data provenance: Not explicitly stated. The tests are benchtop assessments using standardized methods (ISO standards, ADA specifications). The provenance of the data is from Nanova Biomaterials, Inc.'s own testing. No specific country of origin for the data is mentioned beyond Nanova Biomaterials, Inc. being a US-based company. The study is retrospective in the sense that the data was collected prior to the 510(k) submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This was non-clinical benchtop testing, not involving human interpretation or ground truth establishment by experts in that sense.
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Adjudication method for the test set: Not applicable. This was non-clinical benchtop testing.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. The document explicitly states: "Clinical performance data was not included."
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a material device, not an AI algorithm.
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The type of ground truth used: For the physical and mechanical properties, the "ground truth" or reference was established by the specified international standards (ISO 4049, ADA specification 27) and FDA guidance (UCM071576, UCM071631). For biocompatibility, the ground truth was based on ISO 10993 standards. The results (e.g., strength values, pass/fail for biocompatibility) are directly from laboratory measurements against these established standards.
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The sample size for the training set: Not applicable. This is not an AI/machine learning device. The product formulation was "modified to improve physical properties," which would involve research and development, but not a "training set" in the context of AI.
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How the ground truth for the training set was established: Not applicable. (See above).
§ 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.