(36 days)
Extrude Modified is a multiviscosity polyvinylsiloxane impression material system suitable for all crown and bridge, edentulous and implant impression techniques.
Extrude Modified is a multiviscosity polyvinylsiloxane impression material system suitable for all crown and bridge, edentulous and implant impression techniques. Extrude Modified is a two-part, base/catalyst - paste/paste system. The two-part system is packaged either in tubes or cartridges. The product is available in three viscosities, Wash, Medium and Extra.
This document is a 510(k) summary for Extrude Modified, a dental impression material. It does not contain information about acceptance criteria or a study proving that a device meets such criteria. It is a regulatory submission for premarket notification, claiming substantial equivalence to a predicate device.
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§ 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).