(217 days)
rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono is used in the manufacture of a dental core through milling by machine followed by sintering.
rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono is a partially sintered dental ceramic made out of colored ZrO2(Y-TZP). rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono is milled into core (zirconia substructure) of artificial teeth and then is finally sintered in a furnace to harden the ZrO2.
rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono is fabricated by CAD/CAM or MAD/MAM machining processes. At the dental lab, the blanks are held to the milling machine which is used to machine to the final dental restoration. After machining steps, the dental restoration is fully sintered in the furnace to harden the ZrO2, and fitted to the patients as crowns and bridges.
rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono is available in numerous shapes and sizes in order to be compatible with multiple milling machines. According to the shapes, they are used for fabricating of each intended dental restoration, such as anterior crowns, posterior crowns, bridges
rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono is not for use or intended for use to fabricate the top-half of an abutment/titanium base and is for the fabrication of dental restorations only.
The provided text describes the 510(k) premarket notification for the "rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono" dental ceramic. This document is a regulatory submission to the FDA, demonstrating substantial equivalence to a legally marketed predicate device.
The information provided in the document focuses on the bench testing and biocompatibility testing performed on the device to establish its safety and performance characteristics, comparing it to a predicate device. It does not present a study related to AI or human reader performance/improvement, nor does it describe a ground truth establishment process involving experts or pathology for a test set. This is because the device is a dental material (porcelain powder for clinical use), not an AI-powered diagnostic or assistive tool.
Therefore, for the aspects related to AI/human reader studies, ground truth establishment, or MRMC studies, the requested information is not applicable to this specific device and the provided document.
Here's the breakdown of the information that is available in the document, framed by the acceptance criteria provided in your prompt, and noting where the requested information is not relevant to this type of device submission:
Device: rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono (Dental Ceramic)
1. Table of Acceptance Criteria and Reported Device Performance
The provided document details various performance tests, primarily mechanical and chemical, with their acceptance criteria and results.
| No. | Test Item | Acceptance Criteria (Bench Test) | Reported Device Performance (Result) |
|---|---|---|---|
| 1 | Visual | No impurities and No specific changes | Met established specifications |
| 2 | Size | Standard weight |
§ 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.