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The Straumann® Variobase® Abutment is a titanium base placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® Abutments are indicated for screwretained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Straumann® Variobase® Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.

The purpose of the subject submission is to add the previously cleared Straumann n!ce glass ceramic material (K160262) as a cleared material suitable for fabrication of the coping or crown that, when bonded to the previously cleared Variobase abutment base (K142890), forms a finished dental prosthesis. The Straumann Variobase Abutments are pre-manufactured (stock) abutments, sometimes referred to as "Ti-bases". Straumann Variobase Abutments are available to fit Straumann dental implant platforms NNC (Narrow Neck CrossFit®), RN (Regular Neck), WN (Wide Neck), NC (Narrow CrossFit), and RC (Regular CrossFit). A dental laboratory technician would design the corresponding coping and/or crown (the second component of the Variobase two-piece abutment) and/or prosthetic restoration in the dental laboratory via their preferred workflow. The coping and/or crown would be manufactured via traditional laboratory methods for pressing or casting, or via validated Straumann milling.

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