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HIGH SILVER CONVENTIONAL 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.

HIGH SILVER CONVENTIONAL

I am sorry, but the provided text does not contain the acceptance criteria or a study that proves the device meets specific acceptance criteria in the format you requested. The document is a 510(k) premarket notification letter from the FDA to AB Ardent regarding their "High Silver Conventional" amalgam alloy.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements. It also includes an "Indications for Use" section for the device. However, it does not detail specific performance metrics, acceptance criteria, or a study methodology that would allow me to populate the table and answer the study-related questions.

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