(94 days)
EDTA Plus is a root canal cleanser designed to facilitate removal of dentinal debris from the walls of root canals prior to obturation
EDTA Plus is a root canal cleanser for use in endodontic procedures. During/After endodontic instrumentation, the product should be used to clean the canal space and remove the smear layer before placement of the endodontic filling. The material can be delivered into the canal using a side-vented, closed tip irrigation needle.
The device consists of a 16 oz. bottie of EDTA Plus, a peach-colored aqueous solution.
The provided document is a 510(k) summary for a medical device called "EDTA Plus," a root canal cleanser. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details.
The document primarily focuses on:
- Identification of the submitter and device.
- Comparison to predicate devices (SmearClear® and Moyco-EDTA) for the purpose of demonstrating substantial equivalence.
- Device description (16 oz. bottle of peach-colored aqueous solution).
- Intended Use (root canal cleanser to facilitate removal of dentinal debris before obturation).
- The FDA's decision letter granting substantial equivalence (K072555).
In summary, the provided text does not contain the information requested for a detailed description of acceptance criteria and the study proving device performance as it pertains to AI or diagnostic device performance metrics. This type of submission (510(k) for a cleanser) typically relies on demonstrating equivalence to existing products based on composition and known mechanisms of action, rather than clinical performance studies with specific statistical endpoints and ground truth comparisons.
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