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DC Provi Cem Esthetic and DC Provi Cem Esthetic Multi F: Intended for cementing temporary restorations such as crowns, bridges, inlays or onlays; as well as for trial cementing of permanent restorations; DC Provi Cem Implant: Intended for cementing of semi-permanent implants; All cements can also be used as temporary filling materials

Provi Cem Esthetic consist of three different cements: DC Provi Cem Esthetic and DC Provi Cem Esthetic Multi F: Intended for cementing temporary restorations such as crowns, bridges, inlays or onlays; as well as for trial cementing of permanent restorations; DC Provi Cem Implant: Intended for cementing of semi-permanent implants; All cements can also be used as temporary filling materials

This document, specifically the "Summary of Safety and Effectiveness" for Provi Cem Esthetic, is a 510(k) premarket notification. It does not contain information about acceptance criteria or a study proving the device meets said criteria.

Instead, this document focuses on demonstrating substantial equivalence to an already legally marketed device (predicate device). In the context of 510(k) submissions, the manufacturer, S&C Polymer Silicon- und Composite Spezialitaeten GmbH, is asserting that their new device (Provi Cem Esthetic) is as safe and effective as the predicate device (Tempbond Clear, K982590) without the need for new clinical studies to prove performance against specific acceptance criteria.

The information provided confirms the following:

• Device Name: Provi Cem Esthetic (consisting of DC Provi Cem Esthetic, DC Provi Cem Esthetic Multi F, and DC Provi Cem Implant)
• Intended Use:
  • DC Provi Cem Esthetic and DC Provi Cem Esthetic Multi F: Cementing temporary restorations (crowns, bridges, inlays, onlays) and trial cementing permanent restorations.
  • DC Provi Cem Implant: Cementing semi-permanent implants.
  • All cements can also be used as temporary filling materials.
• Predicate Device: Tempbond Clear, K982590.
• Reason for Submission: Demonstrating substantial equivalence to a legally marketed device.

Therefore, I cannot provide the requested table, sample sizes, expert details, adjudication methods, or study results because this document does not contain that information. The 510(k) pathway often relies on comparison to existing devices rather than new performance studies against pre-defined acceptance criteria, especially for Class II devices like dental cements.

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