(88 days)
Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank are used for dental restorations using different CAD/CAM or manual milling machines. All blanks are processed through dental laboratories or by dental professionals.
Dental Zirconia Blank are derived from zirconia powder that has been processed into their final shapes. These blanks are then being further fabricated into all-ceramic restorations such as crowns, bridges, veneers, inlay/onlay. The zirconia powder is composed of ZrO2+ Y2O3+ HfO2+ Al2O3 with its composition conforms to ISO 13356, Implants for surgery - Ceramic materials based on yttriastabilized tetragonal zirconia (Y-TZP). The performance of the dental blanks conforms to ISO 6872, Dentistry - Ceramic materials.
Dental Zirconia Pre-Shaded Blank are derived from the same Zirconia powder as the regular Dental Zirconia Blank with the addition of very small amount of inorganic pigments before the composite material is processed into their final net shapes. These blanks are then being further fabricated into all-ceramic restorations such as crowns, bridges, veneers, inlay/onlay. The purpose of the inorganic pigments is to generate the color on the prosthetic dental devices, after sintering at dental labs, that matches natural color of patient's teeth. The performance of the dental blanks conforms to ISO 6872, Dentistry - Ceramic materials.
This document describes the premarket notification for the "Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank" device, which is a Class II device (Product Code: EIH). The submission aims to establish substantial equivalence to a predicate device (K141724 Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank).
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily based on established international standards for ceramic dental materials and biocompatibility. The reported device performance indicates that the device meets these standards.
| Acceptance Criterion (Standard) | Reported Device Performance and Acceptance |
|---|---|
| Material Composition | |
| Zirconia composition conforms to ISO 13356 for Y-TZP. | Reported: Zirconia powder composed of ZrO2+ Y2O3+ HfO2+ Al2O3 with its composition conforms to ISO 13356. (Pass) |
| Regular Blanks: Zirconia (ZrO2+ Y2O3+ HfO2+ Al2O3) ≥ 99.0% | Reported: Regular Blanks: Zirconia (ZrO2+ Y2O3+ HfO2+ Al2O3) ≥ 99.0%. (Pass - stated as higher than predicate and passed biocompatibility and performance testing) |
| Pre-Shaded Blanks: Zirconia (ZrO2+ Y2O3+ HfO2+ Al2O3) ≥ 99.0% | Reported: Pre-shaded Blanks: Zirconia (ZrO2+ Y2O3+ HfO2+ Al2O3) ≥ 99.0%. (Pass - stated as higher than predicate and passed biocompatibility and performance testing) |
| Inorganic pigments for pre-shaded blanks |
§ 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.