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DC-CORE is a dual cured micro hybride composite for endodontic post cementations and core build-ups (see enclosed page 6 of our actual 510(k) submission !).

DC-Core is a dual cured micro hybride composite.

This document is a 510(k) summary for the DC-Core device, a dental core build-up material. It is a premarket notification for a medical device and therefore describes the device's intended use and substantial equivalence to a predicate device, rather than providing a study demonstrating its performance against specific acceptance criteria.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance studies is not available in this document.

The document establishes:

• Device Name: DC-CORE
• Intended Use: Dual cured micro hybride composite for endodontic post cementations and core build-ups.
• Predicate Device: "BIS-CORE Core Build Up Composite" manufactured by BISCO Dental Products.
• Manufacturer: S & C Polymer GmbH, Germany.
• FDA Determination: The FDA found the device substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

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