(85 days)
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.
§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).