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510(k) Data Aggregation
(227 days)
GenesisZr® UHT700 Zirconia blanks are indicated for Monolitic-ceramic for single-unit anterior or posterior prostleses and for three-unit prostheses not involving molar restoration, adhesively cemented. Also indicated for fully covered substructure for single-unit anterior or posterior prostheses and for three-unit prostheses not involving molar restoration_adhesively, or non-adhesively cemented.
GenesisZr® UHT700 Zirconia are disc and block shaped dental porcelain zirconia oxide blanks that come in various sizes that are used in custom restorations by the dental laboratory. The dental laboratory will further process the blank by milling the blank based upon the anatomically rendering of the patient's teeth (done at the dental office) through "Computer Aided Drafting/ Computer Aided Machining (CAD/CAM). Once the custom rendered blank is milled the product is fully sintered and colored (if required) and fitted to the patient's teeth as a crown.
The provided text describes the 510(k) Premarket Submission for GenesisZr® UHT700 Zirconia. This submission focuses on demonstrating substantial equivalence to a predicate device (CCRI, Inc., Pavati® Z40.2 (K160867)) primarily through non-clinical testing of physical, chemical, and material properties, and comparison of manufacturing processes and indications for use.
Crucially, no information about a study proving the device meets acceptance criteria for an AI or software algorithm is present in this document. The document pertains to a dental material (zirconia blanks) and its physical and chemical properties, not a software device requiring performance metrics like accuracy, sensitivity, or specificity.
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment for a test set or training set. This document does not describe such a study for this medical device.
The only "performance" discussed relates to the material's physical and chemical properties as measured against established dental material standards (ISO 6872:2015 and ISO 13356:2015).
Here's a breakdown of what is available in the document regarding the device's characteristics, which are the basis for its clearance, but not an AI/ML study:
The available document details the non-clinical testing performed to demonstrate substantial equivalence of the GenesisZr® UHT700 Zirconia blanks to the predicate device, Pavati® Z40.2 (K160867). This is a material science characterization, not a performance study of a diagnostic or therapeutic device with AI/ML components.
Here's the relevant information about the acceptance criteria and the "study" (non-clinical testing) that proves the device meets these criteria in the context of a dental material:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally established by international standards for dental ceramic materials (ISO 6872:2015 and ISO 13356:2015) and comparison to the predicate device's properties. The "performance" reported is the measured physical and chemical properties of the GenesisZr® UHT700 Zirconia.
| Property | Acceptance Criteria (from ISO standards / Predicate) | Reported GenesisZr® UHT700 Zirconia Performance |
|---|---|---|
| Sintered Density (g/cm³) | ≥ 6.0 (ISO 13356:2015, Sec. 4.1 Req't.) | 6.04 |
| Thermal Expansion Coefficient (20-500°C) | Comparable to predicate (10.3 µm/m °C) | 10.2 µm/m °C |
| Bending Strength (MPa) | > 600 MPa (and comparable to predicate) | 600 MPa |
| Chemical Solubility (µg/cm²) | 2.0 (and comparable to predicate) | 2.4 |
| ZrO2 + HfO2 + Y2O3+ Al2O3 (%) | > 99.9 | > 99.9 |
| Y2O3 (%) | 9.85% ±0.65 | 9.85% ±0.65 |
| Al2O3 (%) | ≤ 0.1 | ≤ 0.01 |
| SiO2 (%) | ≤ 0.02 | ≤ 0.02 |
| Fe2O3 (%) | ≤ 0.01 | ≤ 0.01 |
| HfO2 (%) | ≤ 5.0 | Not explicitly listed, but implied by total ZrO2+HfO2+Y2O3+Al2O3 > 99.9 |
| Freedom from extraneous materials (Uranium238 Bq g-1) |
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