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UltraTemp is a non-eugenol temporary cement indicated for interim cementation of inlays, orowns and bridges. It is polycarboxylate based and does not negatively affect resin bonding. Being water soluhle until set, it cleans up easily.

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This document is a 510(k) premarket notification from the FDA regarding a dental cement called UltraTemp Temporary Polycarboxylate Cement. It is not an AI/ML device, therefore, the requested information about acceptance criteria, study data, sample sizes, expert ground truth, adjudication methods, and comparative effectiveness studies is not applicable.

The document indicates that the device has been found substantially equivalent to predicate devices marketed before May 28, 1976, and can therefore be marketed subject to general controls provisions of the Act.

The "Indications For Use" section on page 2 defines the purpose of the device:

• Device Name: UltraTemp Temporary Polycarboxylate Cement
• Indications For Use: UltraTemp is a non-eugenol temporary cement indicated for interim cementation of inlays, crowns, and bridges. It is polycarboxylate-based and does not negatively affect resin bonding. Being water-soluble until set, it cleans up easily.

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