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For use in the preparation of root canals prior to the final filling of the root canals in adult or deciduous teeth. The Dentist or Endodontist examines the patient to determine if the method of treatment is to be the removal of the root canal for the appropriate reasons. After opening the tooth with the access bur the first part of the root canal is exposed to the point where the canals tend to branch out about one third of the way. The Dentist then follows his standard procedure of locating the Apex and removal of the nerve and decayed matter from the canal using the Flare--File -- Fill procedures.

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I am sorry, but the provided text does not contain the information required to elaborate on the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) clearance letter from the FDA for a device named "Flare, File, Fill," indicating it is substantially equivalent to a predicate device. However, it does not include details about specific performance criteria, study design, sample sizes, ground truth establishment, or expert qualifications.

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