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SternOmega Compomer Cement Automix is indicated for use in permanent luting of crowns, bridges, inlays and onlays and for luting ceramic crowns, inlays and veneers.

The SternOmega Dental Compomer Cement is an auto-mixing, chemical cure, radiopaque cement indicated for the permanent luting of crowns, bridges, inlays and onlays. The cement contains fluoride which is released over time to provide the benefits associated with a fluoride-releasing material.

The provided document is a 510(k) Premarket Notification for the SternOmega Dental Compomer Cement Automix. It explicitly states that "Substantial equivalence for this device was based solely on design and performance characteristics; no performance or safety data was included in this premarket notification."

Therefore, it is not possible to describe acceptance criteria or a study proving the device meets them from this document. The manufacturer did not submit performance data.

The document indicates that the device's equivalence was based on a comparison to several predicate devices. This means that the FDA determined the new device was substantially equivalent to existing, legally marketed devices based on its intended use, technological characteristics, and design, without requiring a specific performance study from the applicant.

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