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Dental impression material for automatic mixing and dispensing in a PENTAMIX® or PEN-TAMIX® 2 mixing device, resp.: Impressions for inlay, onlay, crown, and bridge restorations Functional impressions Fixation impressions Implant impressions

IMPREGUM® PENTA® M MONOSOFT is classified as an impression material (21 C.F.R. § 872.3660) because it is a device intended to reproduce the structure of a patient's teeth. ESPE is submitting this Special 510(k) for modifications to its polyether based impression material IMPREGUM® PENTA®. The modified material is characterized by its reduced Shore hardness in comparison to IMPREGUM® PENTA®. The reduced Shore hardness of the set impression material results in increased user convenience because the set impression is easier to remove from the mouth. As an additional effect of the reduced Shore hardness, slight undercuts have no longer to be blocked out. The name of the modified material will be, however, IMPREGUM® PENTA® M MONOSOFT. Like IMPREGUM® PENTA®, IMPREGUM® PENTA® M MONOSOFT is an impression material designed for the monophase technique. Like for example IMPREGUM® PENTA® and PERMADYNE® PENTA®, IMPREGUM® PENTA® MONOSOFT is another material intended to be used in ESPE's automatic mixing, dosing and dispensing device, PENTAMIX®.

Dental impression material for automatic mixing and dispensing in a PENTAMIX® or PENTAMIX® 2 mixing device, resp .: Impressions for inlay, onlay, crown, and bridge restorations Functional impressions Fixation impressions Implant impressions

IMPREGUM® PENTA® DUOSOFT is classified as an impression material (21 C.F.R. § 872.3660) because it is a device intended to reproduce the structure of a patient's teeth.