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For use in taking the final Impression of prepared teeth in adult or deciduous teeth when the dentist has determined that a crown or a bridge is needed. The dentist examines the patient and determines the need for a crown or bridge. They then prepare the teeth or tooth in their usual manner. The two component impression material is then mixed manually or automatically and placed into an impression tray of the dentists' choosing. The material is then placed in the mouth and allowed to set, approx. 4 minutes, resulting in an impression of the prepared teeth. The resulting impression is then disinfected and a model is poured from this impression for use by the dentist or dental lab in preparation of the crown or bridge that is to be constructed.

Impression Material

This document is a 510(k) clearance letter from the FDA for a dental impression material, Lone Star Impression Systems. It largely focuses on regulatory aspects and does not contain the kind of detailed performance study data, acceptance criteria, or ground truth information specified in your request.

Therefore, I cannot provide a response that directly addresses your prompt based on the provided text. The document is a regulatory approval, not a scientific study report.

To answer your questions, I would need a clinical study report or a detailed summary of safety and effectiveness data, which typically includes the methodology, results, and statistical analyses of the device's performance.

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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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