(87 days)
DMAX coloring liquid, Chang's liquid, Confident coloring liquid, and CAMeleon coloring liquid can be used as an accessory to zirconium dioxide dental restorative material to provide individual tooth (or teeth) shading. It is intended to be used solely by certified dental technicians for fabrication of zirconium dioxide restorations for individual dental patients.
The subject device is water-based solution. It is used for the individual staining of dental zirconia frameworks and restorations prior to the final sintering. It enables trained dental technicians to adjust the restoration to match the natural color of the patient's teeth. The liquid has 45 shades are available in 15ml, 20ml, 30ml, 40ml and 100ml volumes. We offer the product in four different names: DMAX Coloring Liquid, Chang's Liquid, Confident Coloring Liquid, CAMeleon Coloring Liquid. They are just different names for the same products.
This document describes the premarket notification for DMAX Coloring Liquid and related products. It is not an AI/ML medical device, but rather a dental accessory used for shading zirconia dental restorations. Therefore, the information requested about acceptance criteria and study design from an AI/ML perspective is not applicable here.
However, I can provide the available information regarding the device's performance testing and comparison to a predicate device.
Performance Data (Non-Clinical) - Not AI/ML Specific
The performance data provided is for a dental coloring liquid, not an AI/ML device. The "acceptance criteria" in this context are implicitly met if the test results support substantial equivalence to the predicate device and comply with relevant standards.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is not an AI/ML device, there are no "acceptance criteria" in the typical sense of metrics like sensitivity, specificity, or AUC. Instead, the device's performance is demonstrated through non-clinical bench testing to ensure safety and functionality, and its substantial equivalence to a predicate device is established by comparing characteristics.
| Test Category | Acceptance Criteria (Implicit: Supports Substantial Equivalence to Predicate, meets standards) | Reported Device Performance |
|---|---|---|
| Shelf Life | Passed (implied) | Test results support substantial equivalence to the predicate device. |
| ISO 10993-5 Cytotoxicity | Passed (implied) | Test results support substantial equivalence to the predicate device. |
| ISO 10993-10 Sensitization & Irritation | Passed (implied) | Test results support substantial equivalence to the predicate device. |
| ISO 10993-11 Oral mucosa irritation | Passed (implied) | Test results support substantial equivalence to the predicate device. |
| Appearance | As expected/comparable to predicate (implied) | Test results support substantial equivalence to the predicate device. |
| Volume | As expected/comparable to predicate (implied) | Test results support substantial equivalence to the predicate device. |
| Packaging | As expected/comparable to predicate (implied) | Test results support substantial equivalence to the predicate device. |
| Uniformity | As expected/comparable to predicate (implied) | Test results support substantial equivalence to the predicate device. |
| Chemical Solubility | As expected/comparable to predicate (implied) | Test results support substantial equivalence to the predicate device. |
| pH | 5.5-8.0 | Reported Range: 5.5-8.0 (Subject Device) vs. 6.5-7.2 (Predicate) |
| Boiling Point | 100°C | Reported: 100°C (Subject Device) vs. 100°C (Predicate) |
| Density | 1.00-1.10 g/cm³ | Reported Range: 1.00-1.10 g/cm³ (Subject Device) vs. 1.05-1.10 g/cm³ (Predicate) |
| Specific Gravity | 1.00-1.10 | Reported Range: 1.00-1.10 (Subject Device) vs. 1.05-1.10 (Predicate) |
| Solubility in Water | 100% | Reported: 100% (Subject Device) vs. 100% (Predicate) |
2. Sample Size for Test Set and Data Provenance
This information is not provided in the document. The tests performed are non-clinical bench tests (e.g., in vitro biocompatibility, chemical analysis), not tests involving patient data or clinical samples in the way an AI/ML device would be evaluated.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. The "ground truth" here relates to the chemical and physical properties of the coloring liquid and its biocompatibility, which are determined by established scientific methods and laboratory testing, not by expert interpretation of images or patient data.
4. Adjudication Method
Not applicable. This is not a study involving human readers or interpretations needing adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a non-AI/ML dental accessory.
6. Standalone (Algorithm Only) Performance
Not applicable. This is a non-AI/ML dental accessory.
7. Type of Ground Truth Used
The "ground truth" for this device's evaluation is derived from:
- Bench Test Results: Objective measurements from laboratory tests for physicochemical properties (pH, boiling point, density, solubility) and biocompatibility (cytotoxicity, sensitization, irritation, oral mucosa irritation) according to referenced standards (e.g., ISO 10993).
- Predicate Device Characteristics: Comparison to an already cleared device's known characteristics and performance to establish substantial equivalence.
8. Sample Size for Training Set
Not applicable. This device does not involve a training set as it is not an AI/ML algorithm.
9. How Ground Truth for Training Set Was Established
Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.
Summary of Device and Performance Evaluation:
The DMAX Coloring Liquid family of products are water-based solutions with inorganic pigments used to shade zirconia dental restorations. Their premarket notification to the FDA focuses on demonstrating substantial equivalence to an existing predicate device (LUMINESSE® PRE-SINTERED ZIRCONIA COLORING LIQUID). This is achieved through:
- Comparison of Device Characteristics: Showing similar indications for use, principle of operation, technology (water-based with inorganic pigments), prescription use, target population, general physical form, and sterility to the predicate.
- Bench Testing: Non-clinical tests were conducted according to relevant standards (e.g., ISO 10993 for biocompatibility) for properties such as shelf life, cytotoxicity, sensitization, irritation, oral mucosa irritation, appearance, volume, packaging, uniformity, and chemical solubility. The document states that "All the test results support substantial equivalence to the predicate devices."
- Physicochemical Property Comparison: Specific values for pH, boiling point, density, specific gravity, and water solubility were provided for both the subject device and the predicate device, indicating comparable profiles.
The differences noted (packaging volume, number of shades, shelf life/storage conditions) were deemed not to raise new questions of safety or effectiveness, particularly because the shelf life test results supported equivalence despite different storage duration/conditions.
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.