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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):

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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Imagine h.e. is a dental porcelain that is used by dental technicians to fabricate infagine mor 10 a metal or to press-ceramic restorations. It is suitable for veneering alloys with a high coefficient of thermal expansion [CTE(25 - 500°C): 16.1-16.7 x 10°K']], alleyo www ed restorations, and heat-pressed ceramic frameworks made of the Imagine h.e. Press-Ceramic.

Imagine h.e. can be used for veneering of inlays, partial crowns, crowns, and bridges.

Imagine h.e. is a dental porcelain. It provides an easy to use and aesthetically pleasing dental restorative material to fabricate dental restorations. With its naturescent, brilliant shade effect, Imagine h.e. offers the dental technicians optimum conditions for achieving an exact reproduction of natural teeth.

Imagine h.e. is a dental glass-ceramic containing of leucite crystals (

The provided text does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for a dental porcelain product (Imagine h.e.), detailing its description, classification, and indications for use, along with official correspondence from the FDA confirming substantial equivalence to a predicate device. It does not include performance data or studies against specific acceptance criteria as would be typical for a device with measurable performance metrics.

Therefore, I cannot provide the requested information in the table or address the subsequent points about sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details.

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