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Used as impression materials in a dual phase impression technique. They may also be used for precise duplication of models. Use Regular Set for capturing multiple unit impressions. It is suitable for all impression techniques where the operator needs a monophase, heavy, or low viscosity material. Use Fast Set for capturing one preparation only (single unit crown); ideal for double arch dual phase techniques.

AQUASIL ULTRA MONOPHASE, AQUASIL ULTRA HEAVY, AND AQUASIL ULTRA LV SMART WETTING IMPRESSION MATERIALS are two-part catalyst/base hydrophilic vinylpolysiloxane impression materials used to record details of hard and soft tissues of the oral cavity. They are formulated for regular set and fast set. AQUASIL ULTRA MONOPHASE and AQUASIL ULTRA HEAVY SMART WETTING IMPRESSION MATERIALS are medium viscosity and available in (1:1 ratio) cartridges or (5:1 ratio) for bulk delivery. AQUASIL ULTRA LV SMART WETTING IMPRESSION MATERIAL is a light viscosity and is available in (1:1 ratio) cartridges.

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, sample sizes for test and training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or the type of ground truth used.

The document is a 510(k) summary for a dental impression material (Aquasil Ultra Smart Wetting Impression Material). It describes the device, its intended use, and states that it is substantially equivalent to a previously cleared predicate device (Aquasil Monophase & Heavy and LV™ S.W. Impression Materials K943574). The letter from the FDA confirms this substantial equivalence.

No studies or performance data related to acceptance criteria are mentioned in the provided text.

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