(115 days)
The Obsidian™ Press ceramic is used to fabricate Press Over Metal dental prostheses in the nature of crowns and bridges as well as monolithic dental prostheses in the nature of crowns, veneers, inlays, and onlays for posterior and anterior applications, as well as 3-unit anterior bridges (including pre-molar region as terminal abutment) using pressing methods.
Obsidian™ Press is a lithium silicate ceramic to be supplied in the form of ingots to be pressed to temperature in various furnaces. The increased Obsidian™ Press CTE value is intended to allow the Obsidian™ Press ceramic to be used in Press Over Metal applications, using various approved dental alloys, in addition to the all ceramic applications. The ingots are designed to be pressed into a variety of restorations including Press Over Metal (POM) such as full contour crowns and bridges, as well as monolithic all-ceramic restorations such as full contour crowns, up to 3-unit anterior bridges (including pre-molar region as terminal abutment), inlays, onlays, partial crowns, and veneers with esthetics, translucency, and strength. The ingots will be available in the commonly used VITA Classical and Chromascop Bleach shades.
Here's an analysis of the provided text to extract information regarding acceptance criteria and the supporting study, formatted as requested:
Device Name: Obsidian™ Press (All-Ceramic and POM)
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Predicate Devices & Proposed Device) | Reported Device Performance (Obsidian™ Press) |
|---|---|
| Shades: A1, A2, A3, A35, B1, B2, B3, C1, C2, C3, D2, D3, BL1 and BL4 (for Obsidian™ Ceramic Blocks and IPS 99 One/Ceram) Or High and low translucencies: 16 A-D and 4 Bleach BL shades (for IPS e.max Press) | A1, A2, A3, A35, B1, B2, B3, C1, C2, D2, D3, BL1 and BL4 |
| Flexural Strength: >300 MPa (meeting ISO 6872 requirements) | >300 MPa (meeting ISO 6872 requirements) |
| 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.