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510(k) Data Aggregation
(72 days)
IMAGINE H.E. PRESS DESIGN-CERAMIC
IMAGINE h.e. Press Design-Ceramic is a dental porcelain that can be used by dental technicians for the fabrication of metal free all-ceramic dental restorations.
IMAGINE h.e. Press Design-Ceramic is intended for manufacturing:
- Metall-free single unit restorations in the anterior region and posterior region up to . the second premolar,
- O, MO, or MOD inlays and .
- Onlays, and veneers .
IMAGINE h.e. Press Design-Ceramic is a dental porcelain system, which provides an easy to use and aesthetically pleasing material to fabricate metal-free, all-ceramic dental restorations. It consists of pre-shaded ceramic ingots, which had to be processed in a ceramic press furnace by the dental technicians.
According to ISO 6872, IMAGINE h.e. Press Design-Ceramic is a Type 2, Class 1 dental ceramic, which meets the demands of this standard and even exceeds most given limits.
IMAGINE h.e. Press Design-Ceramic can be used for manufacturing metal-free allceramic single unit restorations in the anterior region and posterior region up to the second premolar, O-, MO- or MOD- inlays, onlays, and veneers.
The Coefficient of Thermal Expansion (CTE) of IMAGINE h.e. Press Design-Ceramic pellets were designed to be exactly compatible with the Coefficient of Thermal Expansion of IMAGINE h.e. Ceramic. Therefore IMAGINE h.e. Ceramic should be used exclusively for the layering or staining techniques.
IMAGINE h.e. Press Design-Ceramic is market and clinically applicated in Europe, particularly in Germany, since February, 2001.
The IMAGINE h.e. Press Design-Ceramic assortment consists of the following ingots (pellets):
| Type of the Pellet | Amount | Shades |
|---|---|---|
| Pellets Naturescence [N] | 16 different shades | [NA1] [NA2] [NA3] [NA3,5] [NA4] [NB1] [NB2] [NB3] |
| [NB4] [NC1] [NC2] [NC3] [NC4] [ND2] [ND3] [ND4] | ||
| Pellets Basic | 16 different shades | [A1] [A2] [A3] [A3,5] [A4] [B1] [B2] [B3] [B4] [C1] [C2] |
| [C3] [C4] [D2] [D3] [D4] | ||
| Pellets Naturescence | ||
| Bleaching [NBL] | 4 different shades | [NBL A01] [NBL A02] [NBL B01] [NBL B02] |
| Pellets Basic Bleaching [BL] | 4 different shades | [BL A01] [BL A02] [BL B01] [BL B02] |
| Transparency Pellets Staining | ||
| Technique [MT] | 11 different shades | [MT01] [MT02] [MT 1] [MT 2] [MTC0] [MTC1] [MTC2] |
| [MTC3] [MTC4] [MTC5] [MTweiß] | ||
| Intensive, opaceous Dentine | ||
| pellets [loD] | 4 different shades | [ioD A] [ioD B] [ioD C] [ioD D] |
Please provide the specific text that contains the acceptance criteria and the study that proves the device meets them. The provided text describes the device (IMAGINE h.e. Press Design-Ceramic) and its intended use, along with regulatory information, but it does not include any section detailing acceptance criteria or the results of a study designed to demonstrate compliance with those criteria.
Typically, acceptance criteria for a medical device (especially in a 510(k) submission) would be related to performance characteristics like strength, biocompatibility, accuracy, or other measurable attributes. The provided text only states: "According to ISO 6872, IMAGINE h.e. Press Design-Ceramic is a Type 2, Class 1 dental ceramic, which meets the demands of this standard and even exceeds most given limits." This sentence indicates compliance with a standard (ISO 6872), but it doesn't provide the explicit acceptance criteria from that standard nor does it detail the specific study results that demonstrate this compliance beyond a general statement.
Therefore, I cannot fulfill your request for the table and study details based on the input provided. If you have another section of the document that outlines these details, please provide it.
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