(88 days)
Delikit is an addition-cure vinyl polysiloxane dental that is used for all crown and bridge, edentulous, orthodontic and implant impression techniques.
Delikit is an addition-cure vinyl polysiloxane dental
I am sorry, but the provided text from the FDA 510(k) summary for the "Delikit" Impression Material does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria in the format requested.
The document is a letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements. It does not include details on performance studies, sample sizes, ground truth establishment, or expert involvement as typically found in a clinical or performance study summary.
Therefore, I cannot provide the requested table and information based on this document.
§ 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).