(383 days)
ICE CERAMICS, ICE CERAMICS TISSUE, ICE CERAMICS DENTINE +, ICE CERAMICS DYNAMIC DENTINE, FRESCO ENAMEL, FRESCO GINGIVA, FRESCO, FRESCO DENTINE + and FRESCO DYNAMIC DENTINE are type I ceramics for coating, staining and glazing dental restorations made of final-sintered zirconia. They are conceived for patients who require dental restorations in zirconia, such as single crowns, bridges, inlays, onlays or veneers.
ICE STAINS, ICE STAINS PRETTAU®, ICE STAINS GLAZE FLUO and ICE STAINS 3D are type I ceramics for coating, staining and glazing dental restorations made of final-sintered zirconia. They are conceived for patients who require dental restorations in zirconia, such as single crowns, bridges, inlays, onlays or veneers.
All devices included in this submission are dental glass ceramics. There are different device types from three device groups: ICE Ceramics Group, ICE Stains Group, and Fresco Group. The devices are supplied in form of powders or pastes and are available in different colors and/ or in different quantity sizes. Specific accessories are supplied for mixing or changing viscosity.
The provided text describes a 510(k) premarket notification for dental glass ceramics (ICE Ceramics, ICE Stains, Fresco) and includes non-clinical testing data to establish substantial equivalence to a predicate device. However, it does not describe a study involving human readers or AI assistance, nor does it present acceptance criteria in terms of diagnostic performance metrics like sensitivity, specificity, or AUC.
Therefore, many of the requested items cannot be answered from the provided document. The device in question is a dental material, not an AI-powered diagnostic tool.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are presented as performance requirements according to the relevant ISO standards for dental ceramics.
| Acceptance Criteria (from ISO 6872) | Reported Device Performance (New Devices) | Meeting Criteria |
|---|---|---|
| Flexural strength ≥ 50 MPa | Flexural strength ≥ 50 MPa | Yes |
| 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.