(95 days)
Dental Direkt zirconium dioxide milling blanks are intended for the fabrication for long-term use.
Dental Direkt zirconium dioxide milling blanks are intended for the restorations for long-term use.
The product is not delivered sterile and cleaning, re-processing or sterilization by the user is not required. The individual variants are available in six heights (12 mm, 16 mm, 25 mm and 30 mm) to meet customer requirements. To achieve the appearance of natural tooth, the raw materials are partially mixed with a coloring of the blank. The variants of the Nacera® Pearl Natural have a color gradient from light (occlusal) to dark (tooth neck) within the blank. In this way, the color gradient of the natural tooth is reproduced.
I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) premarket notification letter for a dental device (DD Hybridlayer (multicolored zirconia)). It discusses regulatory aspects such as the device's classification, general controls, and compliance with regulations like the Quality System (QS) regulation, Unique Device Identification (UDI) System rule, and medical device reporting (MDR).
It mentions "Non-Clinical and/or Clinical Tests Summary & Conclusions," but the content under this heading only states that "Physical characteristics are comparable since the Subject Device is a combination of the Predicate Device," without providing any specific test results, acceptance criteria, or study details.
Therefore, I cannot provide the requested information, including the table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set information.
§ 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.