(49 days)
The Obsidian™ Milling Blocks is used to fabricate ceramic dental prostheses in the nature of crowns and bridges for posterior and anterior applications using CAD/CAM methods.
The Obsidian™ Milling Blocks are a lithium silicate ceramic to be supplied with or without an attached mandrel to be milled using CAD/CAM methods. The product can produce a variety of monolithic restorations with great esthetics, lifelike translucency, and high strength including full-contour crowns, inlays, onlays, veneers partial crowns and substructures due to its excellent machining properties. The milling blocks will be available in the commonly used VITA Classical and Chromascop Bleach shades.
Here's a breakdown of the acceptance criteria and study information for the Obsidian™ Milling Blocks, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Predicate) | Reported Device Performance (Proposed Device) | Substantial Equivalence |
|---|---|---|
| Indications for Use: Fabricate ceramic dental prostheses (crowns and bridges) for posterior and anterior applications using CAD/CAM or hot-press methods. | Indications for Use: Fabricate ceramic dental prostheses (crowns and bridges) for posterior and anterior applications using CAD/CAM methods. | Same (Proposed explicitly states CAD/CAM, but overall use is consistent) |
| Composition: Provided in Section 011 (though not detailed in the comparison table) | Composition: Provided in Section 011. Additional materials were added (details in section 011). | Difference (Additional materials were added, but deemed not to introduce new safety/effectiveness issues) |
| Shades: A1, A2, A3, A35, B1, B2, B3, C1, C2, C3, D2, D3, BL1, BL4 | Shades: A1, A2, A3, A35, B1, B2, B3, C1, C2, D2, D3, BL1, BL4 | Same |
| Flexural Strength: >300 MPa (meeting ISO 6872 requirements) | Flexural Strength: >300 MPa (meeting ISO 6872 requirements) | Same |
| Chemical Solubility: |
§ 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.