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RC SwiftPrep™ Gel is a root canal cleanser designed to etch, cleanse, and debride root canal walls, while removing smear layers prior to obturation. It facilitates efficient instrumentation and promotes optimal sealing of the canal.

RC-SwiftPrep is a root canal cleanser in gel form.

Unfortunately, the provided FDA 510(k) clearance letter for RC-SwiftPrep does not contain any information about the acceptance criteria or the study that proves the device meets those criteria.

FDA 510(k) clearance letters primarily focus on:

• Substantial Equivalence Determination: Stating that the device is substantially equivalent to a legally marketed predicate device.
• Regulatory Information: Details about regulatory classification, product codes, and general controls.
• Administrative Information: Submission numbers, dates, contact information, and disclaimers.
• Indications for Use: A brief description of what the device is intended for.

The letter explicitly mentions that the general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. It does not delve into the specific performance studies, acceptance criteria, or statistical analyses that would have been submitted by the manufacturer as part of their 510(k) application. This kind of detailed study information is typically found in the full 510(k) submission, which is generally not publicly released in its entirety.

Therefore, I cannot provide the information requested in your prompt based solely on the provided FDA clearance letter. To answer your questions, one would need access to the actual 510(k) submission data provided by Belport Company, Inc. to the FDA, which is not included here.

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