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Crown Delta's Hydrophilic vinyl polysiloxane impression material will be used for making impressions of the teeth and gums of patients requiring models for study and/or for production inflorotive of the testic devices. The impression material is intended to be applied via a dual be rooterative prosem either into an impression tray or directly onto the patient's teeth. The "hydrophilic" enhancement will enable production of more accurate impression when adverse conditions (e.g. the presence of blood or saliva) are present.

Crown Delta Hydrophilic Impression Material is a hydrophilic vinyl polysiloxane impression material.

The provided document is a 510(k) premarket notification letter from the FDA regarding the "Crown Delta Hydrophilic Impression Material." This document does not contain any information about acceptance criteria or a study proving the device meets said criteria.

The letter is a regulatory approval document confirming that the device is substantially equivalent to legally marketed predicate devices. It discusses:

• Trade/Device Name: Crown Delta Hydrophilic Impression Material
• Regulation Number/Name: 872.3660, Impression Material
• Regulatory Class: II
• Product Code: ELW
• Indications for Use: Making impressions of teeth and gums for models, applied via a dual syringe system into a tray or directly onto teeth. The hydrophilic enhancement aims for more accurate impressions in adverse conditions (e.g., blood or saliva).

To answer your specific questions regarding acceptance criteria and a study, this document does not provide the required details. Such information would typically be found in the manufacturer's 510(k) submission itself, which is a much more extensive technical document, or in a separate clinical study report.

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