(318 days)
Dynax® Dental Impression Material is intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums.
Dynax® Dental Impression Materials are designed for dental applications to define and reproduce the structure of a patient's teeth and gums for producing crowns, bridges, occlusal and dental implant. Base and catalyst components are mixed in equal ratio 1:1, placed into an impression tray and inserted into the patient's mouth. The material will conform to the patient's dentition and when set will produce a reproduction of the patient's teeth and occlusion.
The acceptance criteria and study proving device performance are detailed below based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Predicate Device K053427 Fresh Bold) | Reported Device Performance (Dynax® clear, putty, heavy body, light, mono) |
|---|---|---|
| Working / Processing time | 90 - 120 sec | 90 sec |
| Setting time / Time in the mouth | 120 - 140 sec | 90 sec |
| Hardness | 42 - 70 Shore A | 46 - 70 Shore A |
| Working humidity | 50 % | 50 % |
| Dimensional accuracy | 99.9 % - 99.2 % | 99.9 % - 99.2 % |
| Stability (linear dimensional change) |
§ 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).