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510(k) Data Aggregation
(89 days)
Ceramill Zolid HT+ white
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) |
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