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MIST IC abutments are intended for use to support a prosthetic device in a partially or completely edentulous patient. They are intended to support a single-unit or multi-unit, cement-retained prosthesis in the mandible or maxilla. MIST IC abutments are compatible for use with the following implants:

Keystone Dental Implant Line Platform Diameter (mm) Body Diameter (mm) Genesis 3.8, 4.5, 5.5, 6.5 3.8, 4.5, 5.5, 6.5 PrimaConnex® 1.0 (Straight) 3.5, 4.1, 5.0 3.3, 4.0, 5.0 PrimaConnex® 1.0 (Tapered) 3.5, 4.1, 5.0 3.5, 4.1, 5.0

All digitally designed custom abutments for use with MIST IC abutments are to be sent to an Imagine Milling Technologies validated milling center for manufacture.

MIST IC abutments include three abutment designs, MIST IC S-LINK, and MIST IC S-LINK, and MIST IC PREFIT, having connections compatible with three Keystone Dental implant systems. Subject device are provided in three interface connection diameters (SD (3.5 mm), RD (4.1 mm) and WD (5.0 mm)). All subject device abutments have the same connection type to the compatible Keystone Dental implants cleared in K101545 and K051614. Corresponding compatible implant platform diameters range from 3.5 mm to 6.5 mm. Corresponding compatible implant body diameters range from 3.3 mm. All sizes of the compatible Keystone Dental implants have one of the three interface connection sizes (SD, RD, and WD).

All subject device L-LINK and S-LINK abutments are two-piece abutments to be used as a base when fabricating a CAD/CAM customized restoration where the superstructure produced will compose the second part of the twopiece abutment; the assembly becoming a final finished medical device after cementation on the subject device abutment. The zirconia superstructure will be fabricated using a CAD/CAM process. MIST IC S-LINK has a cut out in the post to accommodate a restoration with an angled screw channel when clinically necessary. MIST IC PREFTT abutments are titanium cylindrical abutments designed for patient specific abutment fabrication using a CAD/CAM process. All patient-specific abutment fabrication on the order of the clinician.

Design parameters for the L-LINK zirconia superstructure are: minimum wall thickness -0.5 mm; minimum post height for single-unit restoration - 4.0 mm; maximum gingival height - 5.0 mm; and maximum angle - 20°.

Design parameters for the S-LINK zirconia superstructure are: minimum wall thickness - 0.7 mm; minimum post height for single-unit restoration - 4.0 mm; maximum gingival height - 5.0 mm; and maximum angle - 20°.

Design parameters for the PREFIT patient specific abutment are: minimum wall thickness - 0.5 mm; minimum post height for single-unit restoration - 4.0 mm; maximum gingival height - 5.0 mm; and maximum angle - 30°.

All subject device components (abutments and abutment screws) are made of titanium alloy conforming to ASTM F136. Zirconia superstructures for subject device abutments are made of Y-TZP conforming to ISO 13356.

All subject device components are provided non-sterile, and are intended to be end-user sterilized.

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