(139 days)
VPS 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.
VPS Impression Material is dental Impression Material. It complies with the requirements of ISO 4823:2015 for dental elastomeric impression materials. It is supplied as a two-part base/catalyst formulation preloaded in a dual-barrel cartridge. The VPS Impression Material package includes four dual-barrel 50ml cartridges.
The provided text is a 510(k) summary for a dental impression material. The document demonstrates substantial equivalence to predicate devices, rather than proving a device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding study details and expert adjudication is not present in this document.
However, I can extract the acceptance criteria and performance data for the device based on the non-clinical performance tests presented.
Here's the information derived from the document:
1. A table of acceptance criteria and the reported device performance
| Physical Parameters | Acceptance Criteria (Standard ISO4823) | Reported Device Performance (K191034) |
|---|---|---|
| Consistency | ≤35mm | 31 mm |
| Working time | ≥1'30" | 2' |
| Detail reproduction | 50μm | complies (implicitly meets 50μm) |
| Linear dimensional change | ≤1.5% | 0.16% |
| Compatibility with gypsum | 50μm | complies (implicitly meets 50μm) |
| Elastic recovery | ≥96.5% | 99.06% |
| Strain-in-compression | >0.8% |
§ 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).