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510(k) Data Aggregation
(122 days)
ArgenZ Liquids are intended to be used by trained dental technicians as an accessory for shading ArgenZ allzirconia, monolithic restorations for anterior and posterior dental prosthetics.
ArqenZ Zirconia Coloring Liguids are dilute aqueous solutions of transition and lanthanoid metal salts used in combination with ArgenZ Zirconia material (K071410 and K150919) to properly shade teeth. Elements, which may include (but are not limited to) Co, Cr, Er, Fe, Mn, Pr, Ni, Bi, and Nd are combined with water to result in the finished product.
The provided text describes Argen Corporation's ArgenZ Liquids, which are dental coloring liquids for zirconia restorations. The document is a 510(k) premarket notification for the device, seeking substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Product Standard BS EN ISO 6872:2015) | Criteria | Reported Performance (ArgenZ Liquids) |
|---|---|---|
| Flexural Strength | ||
| ArgenZ HT+ | >= 800 MPa | 1230 MPa |
| ArgenZ HT+ Shaded with ArgenZ HT Liquid (A4) | >= 800 MPa | 1223 MPa |
| ArgenZ Anterior | >= 500 MPa | 868 MPa |
| ArgenZ Anterior Shaded with ArgenZ ST Liquid (A3) | >= 500 MPa | 765 MPa |
| ArgenZ Anterior Shaded with ArgenZ ST Liquid (C4) | >= 500 MPa | 963 MPa |
| Chemical Solubility | ||
| ArgenZ HT+ | < 100 ug/cm² | 4.16 ug/cm² |
| ArgenZ HT+ Shaded with ArgenZ HT Liquid (A4) | < 100 ug/cm² | 4.16 ug/cm² |
| ArgenZ Anterior | < 100 ug/cm² | 20.80 ug/cm² |
| ArgenZ Anterior Shaded with ArgenZ ST Liquid (A3) | < 100 ug/cm² | 10.32 ug/cm² |
| ArgenZ Anterior Shaded with ArgenZ ST Liquid (C4) | < 100 ug/cm² | 8.30 ug/cm² |
| Cytotoxicity (ISO 10993-5) | Reactivity grade <= 2 (mild reactivity) | All test articles showed no evidence of cell lysis or toxicity (i.e. grade <= 2). |
2. Sample Size for Test Set and Data Provenance
- Mechanical & Chemical Properties: The document does not specify the exact sample size for each test (flexural strength and chemical solubility). It mentions "test records of parent materials and representative accessories infused into the parent materials," and lists several variations (e.g., ArgenZ HT+, ArgenZ HT+ Shaded with ArgenZ HT Liquid (A4)). The provenance is not explicitly stated, but these are laboratory tests conducted by the manufacturer.
- Cytotoxicity: The document states that "test articles for the cytotoxicity testing were selected as representative samples for each product family, and determined to be worst case scenarios for potential biocompatibility issues." Four specific liquid/zirconia combinations were selected as representative samples (ST on K150919 (A3), ST on K150919 (C4), HT on K071410 (A4), HT on K071410 (B4)). The provenance is not explicitly stated, but these are laboratory tests conducted by the manufacturer.
3. Number of Experts and Qualifications
This document describes a pre-market notification for a dental material, not a diagnostic device involving human interpretation. Therefore, there are no "experts" in the context of establishing ground truth for diagnostic accuracy, nor qualifications for such experts. The evaluation relies on standardized material testing.
4. Adjudication Method
Not applicable, as this is related to material properties testing, not human interpretation of diagnostic results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a dental coloring liquid used by trained dental technicians, not a diagnostic tool where human readers assess cases. The study focuses on material properties, not reader performance.
6. Standalone (Algorithm Only) Performance
Not applicable. This device is a material, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for the performance evaluation is based on product standards (BS EN ISO 6872:2015 for mechanical and chemical properties, and ISO 10993-5 for cytotoxicity). These standards define the acceptable limits for various material properties.
8. Sample Size for Training Set
Not applicable. This is a material, not a machine learning model, so there is no training set in the conventional sense. The "training" in manufacturing refers to established processes and quality control.
9. How Ground Truth for Training Set was Established
Not applicable, as there is no training set for an AI/algorithm. For materials, the "ground truth" for manufacturing involves adherence to established specifications, quality control procedures, and compliance with relevant industry standards and regulations.
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