(135 days)
VITA YZ® ST and VITA YZ® XT materials are blanks used for fabricating dental restorations.
VITA YZ® ST is indicated for fully anatomical anterior crowns, multi-unit fully anatomical anterior and posterior bridges, fully anatomical crowns and multi-unit bridges on direct screw-retained restorations, and single-tooth and multi-unit bridge frameworks of anterior and posterior crowns and bridges.
VITA YZ® XT is indicated for fully anatomical anterior and posterior crowns, fully anatomical 3-unit anterior and posterior bridges, and anterior and posterior single-tooth and 3-unit bridge frameworks.
VITA YZ ST and VITA YZ XT discs are pre-sintered zirconia materials, partially stabilized with yttrium oxide (Y-TZP, yttria stabilized tetragonal zirconia polycrystal). VITA YZ ST is made of Super Translucent Zirconia and VITA YZ XT is made of Extra Translucent Zirconia. They offer higher translucency to better match natural dentition.
This document describes the premarket notification (510(k)) for two dental materials, VITA YZ ST and VITA YZ XT (zirconia blanks for fabricating dental restorations).
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative sense for all attributes. Instead, it refers to meeting specific international standards and demonstrating "similar" properties to predicate devices. For mechanical strength, a direct comparison is given.
| Acceptance Criteria / Standard Met | Reported VITA YZ ST Performance | Reported VITA YZ XT Performance | Predicate (VITA IN-CERAM YZ) Performance | Predicate (priti® multidisc Zr02 HT) Performance |
|---|---|---|---|---|
| Material Composition (similar to predicate) | Yes | Yes | Identical Yttrium-Stabilized Zirconia | Similar Zirconia |
| Physical Properties (similar to predicate) | Yes | Yes | Yes | Yes |
| Indications for Use (similar to predicate) | Yes | Yes | Yes | Yes |
| Meet ISO 6872:2015 – Dentistry, Ceramic materials (requirements) | Yes | Yes | Yes | Yes |
| Meet EN ISO 9693-2:2016 – Dentistry, Compatibility Testing, Ceramic-ceramic systems (requirements) | Yes | Yes | Not explicitly stated for predicate | Not explicitly stated for predicate |
| Meet Biocompatibility requirements per ISO 10933-1:2009 | Yes | Yes | Yes | Yes |
| Meet Biocompatibility requirements per ISO 7405:2008 | Yes | Yes | Yes | Yes |
| Flexural Strength (MPa) | 934 ± 104 MPa | 678 ± 62 MPa | 1165 ± 56 MPa | > 650 MPa |
Note: For many criteria, the "performance" is stated as meeting a standard or being "similar" rather than a specific numerical result. The flexural strength is the most quantitative comparison provided. The conclusion explicitly states that "The differences between VITA YZ ST & VITA YZ XT and the predicate devices do not impact safety and effectiveness, as VITA YZ ST & VITA YZ XT share same indications as the predicate devices, meet the same biocompatibility, and ISO 6872 test criteria."
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical data or human-derived data. All performance testing described is non-clinical (bench testing) and biocompatibility testing.
- Sample Size for Bench Tests: Not explicitly stated for flexural strength or other mechanical/physical properties. Standard testing methods (e.g., ISO 6872) typically define minimum sample sizes for such tests.
- Data Provenance: The data is generated from non-clinical bench testing. The country of origin for the testing is not specified, but the applicant (VITA Zahnfabrik H.Rauter GmbH Co.) is located in Germany.
- Retrospective or Prospective: Not applicable as no clinical data or human studies were conducted.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. "Ground truth" in the context of clinical diagnosis or interpretation by experts is not relevant here, as this is a materials science evaluation and not a diagnostic device. The "truth" is established by conformance to international material standards and laboratory measurements.
4. Adjudication Method for the Test Set
Not applicable, as no expert adjudication involving human readers/interpreters was performed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The device is a dental material, not a diagnostic or AI-assisted diagnostic device. The study focused on material properties and biocompatibility.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a material for fabricating dental restorations, not an algorithm.
7. The Type of Ground Truth Used
- For material properties (e.g., flexural strength, compliance with ISO 6872): The "ground truth" is defined by the requirements of the international standards (e.g., ISO 6872) and measurable physical properties determined through laboratory testing using standardized methodologies.
- For biocompatibility: The "ground truth" is established by conformance to the requirements of the international standards for biocompatibility (ISO 10993-1 and ISO 7405) through specific biological evaluation tests.
8. The Sample Size for the Training Set
Not applicable. No "training set" in the context of machine learning or AI development was used, as this is a material science product.
9. How the Ground Truth for the Training Set was Established
Not applicable. No training set was used.
§ 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.