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DentMix VPS Impression Material is intended for use with all crown and bridge, occlusal and implant impression techniques to reproduce the structure of a patient's teeth and gums.

DentMix VPS Impression Material is an addition-reaction base/catalyst polyviny/siloxane dental impression material intended as an alternative to traditional alginate materials. It is available in regular set and fast set. Both are available in light body, regular body/monophase and heavy body.

The PrimeLOC Attachment System is designed to facilitate patient removal of a dental prosthesis for use with full arch overdentures or partial dentures retained in whole or in part by endosseous implants in the mandible or maxilla.

The PrimeLOC Attachment System consists of abutments and device-specific accessories (retention inserts and denture housings) to serve in a similar function to LOCATOR® abutments for resilient attachment of prostheses to endosseous dental implants. All PrimeLOC abutments are made of titanium alloy and have the same coronal ridge retention design that attaches to the overdenture component by an interference (snap) fit. The threaded apical end of the abutment connects to the implant and is specific to each compatible implant system and diameter. The PrimeLOC Attachment System is designed to accommodate a path of insertion divergence of up to 20° per implant and no more than 40° of divergence between implants. PrimeLOC abutments are provided with a titanium nitride (TiN) coating and are available in cuff heights up to 6 mm, with an implant interface diameter of 3.5 mm. Retention inserts are fixed within a metal denture housing which is embedded in an overdenture prosthesis. The retention inserts allow for varying levels of retention. This connection allows the denture to be retained on the abutments while the majority of loading is supported by the contact of the denture with the gingival tissue surrounding the mandibular and maxillary ridges. The PrimeLOC Attachment System are compatible with OEM implants, specifically Tapered Screw-Vent 3.5 mm platform dental implants manufactured by Zimmer Dental, Inc. Compatibility is based on agreements with the OEM to ensure that the abutments are designed to fit the corresponding implants. All interfaces of the subject device have been designed and verified by the OEM implant manufacturer. This ensures that the interface of the subject device with the identified compatible implants is appropriate. A thin titanium nitride coating is applied to the PrimeLOC abutments in the area that contacts gingival tissue and in the area that contacts the retention inserts. The denture attachment housing, which sits within the denture, may be colored through a titanium anodization process. This system includes instruments used for seating and removing abutments and retention inserts, and processing inserts, impression copings, and laboratory components used to facilitate the fixation of the retention insert and denture housing in the appropriate position within the denture. These components are endosseous dental implant accessories considered Class I 510(k)-exempt devices as defined in 21 CFR 872.3980.