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System for cleansing, sealing and filling of root canals consisting of 3 products: Canal Cleaner, DC Canal Seal SE, and DC Root XR.
Canal Cleaner is a carbamide-peroxide and EDTA-containing gel in syringes for use in the effective cleansing of the root canal during root canal preparation.
DC Canal Seal SE is a simple to use selfetching dual cure sealer for conditioning of root canals and for sealing of side tubuli.
DC Root XR is a dual cure flowable root canal sealing and filling material based on methacrylates.

System for cleansing, sealing and filling of root canals consisting of 3 products: Canal Cleaner, DC Canal Seal SE, and DC Root XR.
Canal Cleaner is a carbamide-peroxide and EDTA-containing gel in syringes.
DC Canal Seal SE is a selfetching dual cure sealer.
DC Root XR is a dual cure flowable root canal sealing and filling material based on methacrylates.

The provided text is a 510(k) clearance letter from the FDA for a dental device called "Root Canal XR". This letter grants clearance based on substantial equivalence to a predicate device. It addresses regulatory compliance rather than presenting clinical study results with acceptance criteria.

Therefore, the requested information regarding acceptance criteria, device performance, study details (sample sizes, provenance, expert ground truth, adjudication), MRMC studies, standalone performance, and training set information cannot be extracted from this document.

This document primarily:

• States the device name and regulation number.
• Confirms substantial equivalence to a predicate device.
• Outlines general regulatory requirements for the manufacturer.
• Specifies the "Indications for Use" for the three products comprising the Root Canal XR system (Canal Cleaner, DC Canal Seal SE, and DC Root XR).

There is no mention of performance metrics, clinical studies, or criteria for device acceptance in terms of efficacy or safety data in this clearance letter.

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