(115 days)
Luminesse ZR Blanks are intended for CAD/CAM fabrication of all-ceramic ( no metal ) dental restorations. Luminesse ZR Blanks are partially sintered Yttria stabilized zirconia blanks for use as CAD/CAM milling blanks. They are isostatically cold pressed so they can be milled using any compatible CAD/CAM machine such as Sirona InLab by Sirona Dental Systems, LLC, Charlotte, NC or KaVO Everest by KaVo Dental, Lake Zurich, IL.
After the ZR Blank is milled, it is sintered, causing the materials to densify into a high strength ceramic material which is suitable for dental inlays, onlays, crowns and bridges.
Luminesse Zirconia blanks, are high purity, bisque fired zirconia machining blanks. The powders pressed to form these blanks are of a uniform size and well dispersed, ensuring no agglomerates. The resultant fine grained, bisque body allows intricate shapes to be machined with tight tolerances. Luminesse Zirconia blanks are phase stabilized with 3 mol % yttria and therefore do not undergo the usual phase transitions associated with pure zirconia. This phase transformation "toughens" the zirconia and stops crack propagation, yielding high fracture toughness and high strength. The highest purity powders are used to make Luminesse Zirconia Blanks minimizing trace oxides. Luminesse Blanks are 99.9 wt% ZrO 2+ Y20 3 + HfO2 + A1203. The natural zirconia minerals HfO2, which is so similar in structure and chemical properties to zirconia, that it has no effect on product properties. A small addition of alumina minimizes hydrothermal aging.
Luminesse Zirconia Blanks are dental ceramic blanks designed for the manufacturing of substructures for ceramic dental appliances. The dental appliance is machined either by CAD/CAM machining or using the copying technique. All appliances are for the sole use of the particular patient only. A metal chuck is glued on the end of blank or a metal ring that holds it in the CAD/CAM machine which is used to machine the final dental restoration. After completion of the machining steps, the dental restoration is fired (i.e., sintered) in the oven to harden the ZrO 2.
Luminesse ZR Blanks are intended for CAD/CAM fabrication of all-ceramic ( no metal ) dental restorations. Luminesse ZR Blanks are partially sintered Yttria stabilized zirconia blanks for use as CAD/CAM milling blanks. They are isostatically cold pressed so they can be milled using any compatible CAD/CAM machine such as Sirona InLab by Sirona Dental Systems, LLC, Charlotte, NC or KaVO Everest by KaVo Dental, Lake Zurich, IL.
After the ZR Blank is milled, it is sintered, causing the materials to densify into a high strength ceramic material which is suitable for dental inlays, onlays, crowns and bridges.
The provided text describes a 510(k) summary for "Luminesse Zirconia Blanks," which are dental ceramic blanks for manufacturing substructures for ceramic dental appliances. This submission argues for substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a new device's functionality. Therefore, many of the requested points related to device performance studies, ground truth, and expert evaluation are not directly applicable or provided in this document.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not present specific acceptance criteria for device performance for Luminesse Zirconia Blanks. Instead, it states that the predicate device, IPS e.max ZirCAD by Ivoclar (K051705), used the Biaxial Performance Criteria: Strength method to test Flexural Strength (ISO 6872) and Chemical Solubility for mass loss (ISO 6872) using a 4% solution of acetic acid.
The submission claims that "Since the predicate and proposed devices are exactly identical in formulation, there is no need for further testing." This implies that the Luminesse Zirconia Blanks are expected to perform comparably to the predicate device, meeting the same (unspecified in this document) performance criteria as evaluated for the predicate device.
Table of (Implied) Acceptance Criteria and Reported Device Performance:
(Based on the predicate device's testing and the claim of identical formulation)
| Performance Characteristic | Acceptance Criteria (Implied from Predicate) | Reported Device Performance (Luminesse Zirconia Blanks) |
|---|---|---|
| Flexural Strength | Meets ISO 6872 Biaxial Performance Criteria | Assumed to meet (due to identical formulation to predicate device) |
| Chemical Solubility | Meets ISO 6872 (4% acetic acid mass loss) | Assumed to meet (due to identical formulation to predicate device) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
No specific test set or data provenance is mentioned for the Luminesse Zirconia Blanks as direct testing was not conducted. The reliance is on the predicate device's data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. No ground truth establishment by experts for a test set is mentioned for the Luminesse Zirconia Blanks. The basis for equivalence is material composition.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No adjudication method for a test set is mentioned.
5. 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 device is a material for dental restorations, not an AI or imaging diagnostic tool that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" in this context is the performance of the predicate device based on standardized material testing (ISO 6872).
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.
§ 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.