(118 days)
Upcera 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 thought dental laboratories or by dental professionals.
Upcera Dental Zirconia Blanks are derived from Zirconia powder that has been 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 zirconia powder is composed of ZrO2 + Y2O3 + HfO2 + Al2O3 with its composition conforms to ISO 13356, Implants for Surgery -- Ceramic Materials Based on Yttria-Stabilized Tetragonal Zirconia (Y-TZP). The performance of the dental blanks conforms to ISO 6872, Dentistry: Ceramic Materials.
Upcera Dental Zirconia Pre-Shaded Blanks are derived from the same Zirconia powder as the regular Upcera Dental Zirconia Blanks, 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 pre-shaded dental zirconia blanks conforms to ISO 6872: 2008, Dentistry: Ceramic Materials.
The document describes the submission of a 510(k) premarket notification for "Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank." The primary goal of the submission is to demonstrate substantial equivalence to a legally marketed predicate device (K093560, "Upcera Zirconia Blanks"). The acceptance criteria and the study used to demonstrate that the device meets these criteria are primarily based on international standards for dental materials.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from the specified ISO standards, and the reported performance indicates compliance with these standards.
| Test / Performance Metric | Acceptance Criteria (from Standards) | Reported Device Performance (Upcera Dental Zirconia Blank & Pre-Shaded Blank) |
|---|---|---|
| Mechanical Properties | ||
| Flexural Strength | Conforms to ISO 6872:2008, Dentistry: Ceramic Materials (Specific values not provided in document, but compliance stated) | "Very similar to the predicate device," met all relevant requirements in test standard. |
| Radioactivity | Conforms to ISO 6872:2008, Dentistry: Ceramic Materials (Specific limits not provided, but compliance stated) | "Very similar to the predicate device," met all relevant requirements in test standard. |
| Pre-sintered Density | Conforms to ISO 6872:2008, Dentistry: Ceramic Materials (Specific values not provided, but compliance stated) | "Very similar to the predicate device," met all relevant requirements in test standard. |
| Sintered Density | Conforms to ISO 6872:2008, Dentistry: Ceramic Materials (Specific values not provided, but compliance stated) | "Very similar to the predicate device," met all relevant requirements in test standard. |
| Biocompatibility | ||
| Cytotoxicity | Conforms to ISO 10993-5:2009 (No cytotoxicity effect) | No cytotoxicity effect |
| Irritation (Oral Mucosa) | Conforms to ISO 10993-10:2010 (Not a primary oral mucosa irritant) | Not a primary oral mucosa irritant under the conditions of the study |
| Sensitization | Conforms to ISO 10993-10:2010 (Not a sensitizer) | Not a sensitizer under the conditions of the study |
| Subacute/Subchronic Toxicity | Conforms to ISO 10993-11:2006 (No subacute and subchronic toxic effects) | No subacute and subchronic toxic effects observed |
| Genotoxicity | Conforms to ISO 10993-3:2003 (No genotoxic effects) | No genotoxic effects observed |
| Composition | Conforms to ISO 13356, Implants for Surgery -- Ceramic Materials Based on Yttria-Stabilized Tetragonal Zirconia (Y-TZP) (Specific composition requirements for ZrO2, Y2O3, HfO2, Al2O3) | Regular: ZrO2 + Y2O3 + HfO2 + Al2O3 ≥ 99.0% |
| Pre-Shaded: ZrO2 + Y2O3 + HfO2 + Al2O3 ≥ 98.0% + Inorganic pigments (Fe2O3, Pr2O3, and Er2O3, |
§ 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.