(105 days)
BruxZir® Incisal Coloring Liquid is intended to be used by trained dental technicians as an accessory for shading BruxZir® Shaded 16 PLUS and BruxZir® Esthetic all zirconia, monolithic restorations for anterior and posterior dental prosthetics.
BruxZir™ Incisal Coloring Liquid comprises a set of solutions that enhance the esthetic properties of zirconia restorations. The solution is applied to the zirconia restorations before sintering, by dipping the framework into the liquid or by using a metal-free brush. Afterwards, the structure is dried and subsequently sintered at temperatures above 1400°C. BruxZit™ Incisal Coloring Liquid is available in 3 different colors, Premium, Premium HT, and Pearl. The devices are used on incisal areas of dental restoration to mimic natural tooth color. The devices are intended to be used solely by dental technicians for fabrication of zirconia restorations for individual dental patients.
The "BruxZir™ Incisal Coloring Liquid" is an accessory for shading zirconia dental restorations. The acceptance criteria and the study proving it meets these criteria are described below:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Device Performance (BruxZir™ Incisal Coloring Liquid) | Standard/Requirement |
|---|---|---|
| Mechanical Properties | Meets minimum mechanical properties of zirconia for Type II, Class 5 | ISO 6872:2015/Amd 1:2018 |
| Flexural Strength | Satisfies requirements for Type II, Class 5 zirconia | ISO 6872:2015/Amd 1:2018 |
| Chemical Solubility | Below 100 ug/cm² limit | ISO 6872:2015/Amd 1:2018 |
| Material Properties | ||
| Biocompatibility | No biocompatibility concern | ISO 10993-1, ISO 10993-5:2009 |
| Functional Properties | ||
| Visual Shade Match | Meets shade match requirements and works as intended | Based on qualified reviewer evaluation against reference shade guides |
| Shelf Life | 0.5 years (accelerated aging) | ASTM F1980-21 |
| Packaging Integrity | Suitable to withstand distribution environment | Similar to reference device (K220960) packaging validation |
2. Sample Size Used for the Test Set and the Data Provenance:
The document doesn't explicitly state the sample sizes for each specific test (e.g., number of restorations tested for flexural strength, number of specimens for chemical solubility). It also doesn't specify the country of origin for the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
For the "Visual Shade Evaluation," the document states "qualified reviewers" performed the evaluation. However, it does not specify the number of reviewers, their professional qualifications (e.g., dental technicians with X years of experience, ceramists), or how "qualified" is defined.
4. Adjudication Method for the Test Set:
For the "Visual Shade Evaluation," it simply states the evaluation was done "against the reference shade guides." No specific adjudication method (e.g., 2+1, 3+1) is described for resolving discrepancies, implying a single reviewer's assessment or a consensus without a formal adjudication process. For other tests, the outcomes are quantitative measurements against established standards, so an adjudication method is not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC comparative effectiveness study was not done. The submission is focused on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
This device is not an AI/algorithm-based device, so the concept of "standalone performance" in that context is not applicable. The device is a coloring liquid used in the fabrication process of dental prosthetics.
7. The Type of Ground Truth Used:
- Mechanical Properties (Flexural Strength, Chemical Solubility): The ground truth is defined by established international standards (ISO 6872:2015/Amd 1:2018), which specify minimum acceptable performance values.
- Biocompatibility: Ground truth is established by international standard (ISO 10993-1, ISO 10993-5:2009) requirements.
- Visual Shade Evaluation: Ground truth is established by "reference shade guides" and evaluation by "qualified reviewers."
- Shelf Life: Ground truth is based on the methodology outlined in ASTM F1980-21.
- Packaging Validation: Ground truth is based on established testing protocols to ensure packaging integrity.
8. The Sample Size for the Training Set:
This device is not an AI/machine learning device, so there is no concept of a "training set" in the traditional sense.
9. How the Ground Truth for the Training Set Was Established:
As there is no training set, this question is not applicable.
§ 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.