(149 days)
Vericore zirconia blanks are made from pre-sintered zirconium dioxide intended to be used with CAD/CAM or manual milling machines. Vericore zirconia blanks are biocompatible and designed to fabricate;
- -Zirconia Substructures
- Restorations (Including inlays, onlays, and veneers) -
- -Crown Framework in the Anterior and Posterior regions
- -Bridge Framework in the Anterior and Posterior regions
Vericore Zirconia Blanks is a device made from pre-pressed and pre-sintered zirconia powder. It is available in various shades, shapes, and sizes to accommodate the customers CAD/CAM or manual milling equipment/strategies and is not machine specific. Vericore Zirconia Blanks are made from a biocompatible zirconia powder. It is intended to be used by professionals for the fabrication of dental restorations.
The provided document is a 510(k) summary for a medical device (Vericore Zirconia Blanks), which primarily focuses on establishing "substantial equivalence" to a predicate device rather than presenting a detailed clinical study for novel device performance. Therefore, many of the requested fields related to clinical study design (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance with AI) are not applicable or findable in this type of submission.
However, I can extract information related to acceptance criteria, device performance, and limited testing details.
Here's the information based on the provided document:
Acceptance Criteria and Device Performance
| Acceptance Criteria (from ISO 6872) | Reported Device Performance (Vericore Zirconia Blanks) |
|---|---|
| Flexural strength (ISO 6872 standard) | Passed (tests performed in accordance with ISO 6872) |
| Thermal expansion (ISO 6872 standard) | Passed (tests performed in accordance with ISO 6872) |
| Chemical solubility (ISO 6872 standard) | Passed (tests performed in accordance with ISO 6872) |
| Density (standard not explicitly stated, but implies a target) | Results recorded in proposed labeling (specific values not provided in this summary) |
| Biocompatibility (ISO 10993 series) | Passed (stated as biocompatible based on predicate device testing) |
Study Details
- Sample size used for the test set and the data provenance: Not explicitly stated for the "test set" in the context of a clinical performance study. The "test set" here refers to the samples of Vericore Zirconia Blanks that underwent bench testing. The provenance of these physical samples would be the manufacturer (Whip Mix Corporation).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device is a material, and its performance is evaluated through physical and chemical property testing (bench testing) against international standards, not against expert human interpretations.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Performance is determined by objective measurements compared to standard thresholds, not by human adjudication of clinical outcomes.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-enabled diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI-enabled device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for the bench tests are the established performance requirements outlined in the ISO 6872 standard for dental ceramic materials and ISO 10993 for biocompatibility.
- The sample size for the training set: Not applicable. This device is a material, not a machine learning model.
- How the ground truth for the training set was established: Not applicable. No training set is involved for this device.
Additional Information from the document:
- Study Type: Bench testing (physical and chemical property evaluation) and comparison to a legally marketed predicate device to establish substantial equivalence.
- Predicate Device: White Peaks Copran ZR/Origin ZR (K092496).
- Basis for Biocompatibility: The document states, "No further biocompatibility tests are necessary because Whip Mix Vericore Blanks are made from the same powder as the predicate," which indicates a reliance on the biocompatibility testing performed for the predicate device (in accordance with ISO 10993-10, 10993-3, and 10993-5).
§ 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.