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Corerestore 2 is a fluoride releasing, resin-based material designed to be used for composite core build-ups. Corerestore 2 can be used in either the dual cure, two part base/catalyst configuration or in the light cure, one part paste configuration.

Corerestore 2 is a fluoride released core build-up material. Corerestore 2 can be used in either the dual cure, two part base/catalyst configuration or in the light cure, one part paste configuration. The product is available in both, high and low viscosities.

This document is a 510(k) summary for Corerestore 2, a dental composite core build-up material. It does not contain any information about acceptance criteria or a study proving that a device meets those criteria.

The document primarily focuses on:

• Device Identification: Trade name (Corerestore 2), common name (Composite Core Build-up Material), and classification name (Tooth shade resin material).
• Substantial Equivalence: Claiming substantial equivalence to Jeneric/Pentron, Inc.'s Build-It and Kuraray Co., Ltd.'s Clearfil Photo Core.
• Intended Use: For composite core build-ups.
• Device Description: Fluoride-releasing material, dual-cure or light-cure configurations, available in high and low viscosities.
• FDA Clearance Letter: Confirmation of 510(k) clearance (K011798) based on substantial equivalence.
• Indications for Use Statement: Reiterating the device's intended use.

Therefore, I cannot provide the requested table or answer any of the questions (1-9) regarding acceptance criteria and study details because the provided text does not contain this information.

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