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VIVACAP HR is to be used as a filling material for restoring function to teeth which have lost portions to caries:

Direct, fixed restorations, placed by the dentist after removal of carious tissue.

Single surface cavities such as Class I

Two surface cavities such as MO, DO, FO, LO

Three surface cavities such as MOD, FOD.

Pinned onlays and half crowns.

Core build-ups for cast half and full crowns.

For use only by dental professional such as DDS or DMD. Not for use by general public or OTC.

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I apologize, but the provided text is a 510(k) clearance letter from the FDA for a dental filling material called VIVACAP HR. This document grants market clearance based on substantial equivalence to a predicate device and details the intended use of the product.

Crucially, this document does not contain any information regarding clinical studies, acceptance criteria for device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them because that information is not present in the provided text.

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