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510(k) Data Aggregation
(89 days)
Zirconium-oxide blanks for permanent and removable dental prosthetics.
Amann Girrbach AG Ceramill® Zolid HT+ white is an all-ceramic core dental material made of Yttria-Stabilized Zirconium Oxide (zirconia, YSZ). It is provided as a disk shape (U-shape or round-shape). CAD/CAM fabrication of core material can then be used to produce copings and substrates for fixed all ceramic dental restorations above the gum line. The material is used for the manufacturing of permanent and removable prosthetic restorations. The material is then fired in an oven to harden the ZrO2. The milling and final oven hardening is completed by the customer (the dental technician).
This document is a 510(k) Pre-market Notification for a dental material, Ceramill® Zolid HT+ white, and focuses on demonstrating its substantial equivalence to a predicate device, Ceramill® ZI. It is not an AI/ML device, so many of the requested criteria regarding AI model performance or human reader studies are not applicable.
Here's an analysis of the provided information based on the request:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (zirconium-oxide blanks for dental prosthetics), acceptance criteria are typically defined by recognized international standards for ceramic dental materials. The study's goal is to show that the new device meets or is equivalent to the predicate device in key performance characteristics relevant to these standards.
| Characteristic | Acceptance Criteria (Predicate Ceramill® ZI) | Reported Device Performance (Ceramill® Zolid HT+ white) | Device Comparison / Acceptance Met |
|---|---|---|---|
| Material Composition | |||
| ZrO2 + HfO2 + Y2O3 | ≥ 99.0% | ≥ 99.0% | Same |
| Y2O3 | 4.5 - 5.6% | 6.7 - 7.2% | Similar (variance, but no new safety/effectiveness concerns) |
| HfO2 | ≤ 5% | ≤ 5% | Same |
| Al2O3 | ≤ 0.5% | ≤ 0.5% | Same |
| Other oxides | ≤ 1% | ≤ 1% | Same |
| Physical Properties | |||
| Sintering Temperature/Duration | 1450°C — 2 hours | 1450°C — 2 hours | Same (Both meet ISO 6872:2015) |
| Shelf Life | 5 years | 5 years | Same |
| Opacity (%) | 69.0 ± 1.5% | 60.0 ± 1.5% | Different (lower opacity/higher translucency, but equivalent high bending strength) |
| Flexural Bending Strength (3-point) (MPa) | 1200 ± 150 (≥8 Weibull modulus) | 1100 ± 150 (≥8 Weibull modulus) | Similar (Both meet ISO 6872:2015 minimum average of 800 MPa; 100 MPa difference not significant; Type II, Class 5) |
| Flexural Bending Strength (4-point) (MPa) | 1000 ± 150 (≥8 Weibull modulus) | 1000 ± 150 (≥8 Weibull modulus) | Same |
| E-module (GPa) | ≥ 200 | ≥ 200 | Same |
| Thermal Expansion Coefficient (CTE) (10⁻⁶/K) (25-500°C) | 10.4 ± 0.5 | 10.4 ± 0.5 | Same |
| Chemical Solubility (µg/cm²) | < 100 | < 100 | Same |
| Vickers Hardness (HV10) | 1300 ± 200 | 1300 ± 200 | Same |
| Final Density (g/cm³) | ≥ 6.07 | ≥ 6.05 | Similar (0.02 difference not significant; Both meet ISO 6872:2015) |
| Porosity (%) | 0 (no open porosity) | 0 (no open porosity) | Same |
| Grain Size (μm) | ≤ 0.6 | ≤ 0.6 | Same |
| Shrinkage | V (L/W): 24.50 - 28.00%; V (H): 23.50 - 28.00%; H < 1 | V (L/W): 22.00 – 24.00%; V (H): 21.00 – 24.00%; H < 1 | Similar (difference in shrinkage, but no influence on performance/safety; a process parameter for dental lab) |
| Radioactivity (Bq/g) | ≤ 1.0 | ≤ 1.0 | Same |
2. Sample Size Used for the Test Set and Data Provenance
This document describes non-clinical bench testing of physical and chemical properties of a dental ceramic. It does not involve a "test set" in the context of clinical data or AI model evaluation. Sample sizes would refer to the number of specimens tested for each physical or chemical property (e.g., number of bars for flexural strength, number of samples for density). These specific sample quantities are not provided in the summary, but the testing was conducted according to recognized international standards (ISO, EN), which would specify appropriate sample sizes for such tests.
The data provenance is from bench testing carried out by Amann Girrbach AG (Austrian manufacturer submitting through a Dutch consultant). This is prospective testing of the device properties.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not a study involving interpretation by experts or establishment of ground truth for a diagnostic test. The "ground truth" for the material properties is established by the direct measurement of its physical and chemical characteristics using standardized methods.
4. Adjudication Method for the Test Set
Not applicable, as this is not a study requiring human adjudication for diagnostic outcomes.
5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study was Done
Not applicable. This is a material science study, not a diagnostic imaging study with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable, as this device is a physical dental material, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is derived from standardized physical and chemical measurements of the material's properties according to ISO and EN standards. These measurements establish the intrinsic characteristics of the ceramic material.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML model, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for this device.
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