(3 days)
Splash!® Dental Impression Material is intended for use with all crowns, bridges, occlusal and dental implant impression techniques to reproduce the structure of a patient's teeth and gums.
Splash!® Dental Impression Material is an addition-reaction base/catalyst polyvinylsiloxane dental impression material. It is available in Regular set or fast-setting Half-time varieties. Both are available in a heavy viscosity and in wild berry flavor, as well as unflavored.
Here's an analysis of the provided information regarding the Splash!® Dental Impression Material, focusing on acceptance criteria and the supporting study details:
Device: Splash!® Dental Impression Material
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Splash!® Dental Impression Material are primarily based on demonstrating substantial equivalence to predicate devices across various physical and chemical properties relevant to dental impression materials. The "acceptance criteria" are implied by the ranges and values observed in the predicate devices which the new device aims to meet or perform comparably to.
| Property | Acceptance Criteria (Implied from Predicates) | Splash!® Dental Impression Material Performance |
|---|---|---|
| Material Type (ISO 4823) | Type 0-3 (Consistent with Precision) or Type 1-3 (Aquasil, P2 Polyether) | Type 0-3 |
| Recovery from Deformation | >98.0% (Aquasil) or 97.5% - 99.6% (P2, Precision) | 99.2% - 99.5% |
| Shrinkage |
§ 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).