(76 days)
The Dental Impression Material is intended for use with all crowns, bridges, and orthodontic impression techniques to reproduce the structure of a patient's teeth and gums.
The Dental Impression Material is a kind of addition-cure rubber impression material composed of vinyl polysiloxane and various fillers, with neutral smell and applicable to impression in dentistry. The Dental Impression Material is very easy to mix and has good dimensional stability, helps to make precise impression taking.
The provided document describes the acceptance criteria and a study for the Nanchang Dental Bright Technology Co., Ltd's Dental Impression Material.
1. Table of Acceptance Criteria and Reported Device Performance:
| Item | Acceptance Criteria (Type 0) | Reported Device Performance | Result |
|---|---|---|---|
| Consistency |
§ 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).