(55 days)
DD cube ONE ML dental zirconia blanks are indicated for crowns, multi-unit bridges and inlay bridges. Applications include both, anterior and posterior bridges.
DD cube ONE ML are dental milling blanks made of yttria-stabilized pre-sintered zirconium dioxide, showing a super high translucency and a high strength and fracture toughness at the same time. The ceramics are of type II (not powder), Class 5 according to DIN EN ISO 6872 (FDA Recognition Number 4-223). The material is suited ideally for crowns and bridges for both, the anterior and posterior region.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: DD cube ONE ML (Dental Zirconia Blanks)
Predicate Device: K170885: Dental Direkt GmbH DD cube ONE (former DD cubeX2 HS)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Requirement from ISO 6872:2015) | Required Value | Achieved Value | Passed / Failed |
|---|---|---|---|
| Uniformity (Clause 5.1) | N/A (Visual Inspection) | - | Passed |
| Freedom from extraneous materials (Clause 5.2.1) | N/A (Visual Inspection) | - | Passed |
| Activity concentration of uranium 238 (Clause 5.2.2) |
§ 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.