(169 days)
Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.
Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blanks are available in various specifications, which are combinations of different dimensions and shapes (Semics, Rods, Blocks and Discs). Furthermore, each specification is available in twenty two (22) color configurations.
This document describes the premarket notification (510(k)) for the "Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank." The submission aims to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are established primarily through conformity to ISO 6872:2008 (Dentistry - Ceramic materials) and ISO 10993 series for biocompatibility. The reported device performance is presented in "Table 1 Results of Non-clinical Tests" and compared against the predicate device in "Table 2 Comparison of Technology Characteristics."
| Item | Acceptance Criteria (typically based on ISO 6872 or ISO 10993 standards) | Reported Device Performance (Nissin Dental Zirconia Blank) |
|---|---|---|
| Radioactivity | Conforms to ISO 6872 (Predicate: |
§ 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.