(28 days)
"Ceramill Zold FX" preshade are blanks made of zirconium oxide (ZrO2) for type II, class 5 dental applications in accordance with DIN EN ISO 6872. They are used for manufacturing permanent and removable prosthetic restorations (e.g., crowns and three-unit bridges to the molar region) using CNC milling machines (e.g., Ceramill Motion).
Amann Girrbach AG "Ceramill Zolid FX" is an all-ceramic core dental material made of Yttria-Stabilized Zirconium Oxide (zirconia, YSZ). It is provided as a disk shape (U-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 (e.g. crowns and three-unit bridges to the molar region). 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).
The document provided describes the submission of a medical device (Ceramill Zolid FX) for FDA clearance, demonstrating its substantial equivalence to a predicate device (Ceramill ZI blanks). The information provided focuses on non-clinical performance data and does not contain details about studies involving human readers or AI assistance. Therefore, some of the requested information, particularly related to human reader studies, AI assistance, and large-scale data sets, is not applicable or available in this document.
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1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for "Ceramill Zolid FX" are based on conformance to applicable national and international standards, primarily ANSI ADA Specification No. 69:2010 (Dental Ceramic) and ISO 6872:2008 (Dentistry – Ceramic Materials), as well as internal specifications.
| Test / Performance Metric | Acceptance Criteria (Standard / Predicate) | Reported Device Performance (Ceramill Zolid FX) |
|---|---|---|
| Material Composition (wt%) | Zirconia (ZrO2 + HfO2 + Y2O3 > 99.0%) (Predicate) | Zirconia (ZrO2 + HfO2 + Y2O3 ≥ 99.0%) |
| Y2O3 | 4.5 - 5.6 (Predicate) | 9.15 - 9.55 |
| Al2O3 | 500 MPa / Meets ISO 13356 & ISO 6872 (Note: Lower than predicate, but still meets standard for its limited indications) | |
| Weibull Modulus | 10.63 (Predicate) / Meets ISO 13356 & ISO 6872 | 9.54 / Meets ISO 13356 & ISO 6872 |
| Hardness (Vicker's Hardness) | 1300 ± 200 HV10 (Predicate) / Meets internal specifications | 1300 ± 200 HV10 / Meets internal specifications |
| Coefficient of Thermal Expansion | 10.4 ± 0.5 *10-6/K (Predicate) / Meets ISO 9396 & ISO 6872 | 10.1 ± 0.5 *10-6/K / Meets ISO 9396 & ISO 6872 |
| Modulus of Elasticity | >200 GPa (Predicate) / Meets internal specifications | >200 GPa / Meets internal specifications |
| Radioactivity (raw material) |
§ 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.