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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: | Compatible Implant System | Implant Body Diameter, mm | Implant Platform Name | |---|---|---| | Straumann Bone Level (CrossFit® Morse Taper) | 2.9 | SC | | | 3.3 | NC | | | 4.1, 4.8 | RC | | Straumann® Tissue Level (CrossFit® Connection) | 3.3, 4.1, 4.8 | RN | | | 4.8 | WN | | Straumann BLX (TorcFit™ Internal Hexalobular) | 3.5, 3.75, 4.0, 4.5 | RB | | | 5.0, 5.5, 6.5 | WB | | Neodent GM (Morse taper) | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | Grand Morse (GM) | 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 from Imagine Milling Technologies, LLC is a line of Ti-base and machinable blank abutments to interface with compatible dental implants from four (4) manufacturers, and a total of eight (8) implant-abutment interface compatibilities. The subject device prosthetic platform diameters range from 3.8 mm to 6.9 mm. All stock subject device components (abutments and abutment screws) are made of titanium alloy conforming to ASTM F136. The subject device MIST IC L-LINK abutments have a TiN coating achieved through a physical vapor deposition (PVD) process that is identical to the process used for TiN coating of Imagine Milling Technologies, LLC devices cleared in K222368. The PVD cathodic arc evaporation process is a high current, low voltage process in which material evaporated from the cathode (Ti) is ionized, transported through the vacuum chamber with reactive gas (N2) and deposited as a non-porous, thin film on the titanium substrate. Each abutment is supplied with the non-sterile abutment screw designed for attachment to the corresponding compatible OEM implant. All patient-specific abutment fabrication for all MIST IC abutments is by prescription on the order of the clinician. All MIST IC abutments are intended to be milled at an Imagine Milling Technologies, LLC validated milling center under FDA quality system regulations. MIST IC L-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 two-piece abutment; the assembly becoming a final finished medical device after cementation on the subject device abutment. They are provided with engaging and non-engaging connections. The L-LINK abutments and corresponding zirconia superstructure are provided to the clinician either with the superstructure cemented to the abutment by the dental laboratory, or separately for the clinician to bond together chairside using the cement required in the labeling (RelyX RMGIP bonding cement, cleared in K022476). The design parameters for L-LINK patient-specific abutments are: - Minimum wall thickness – 0.5 mm - Minimum cementable post height for single-unit restoration – 4.0 (minimum cementable post height for single-unit restoration is defined as the height above the restorative margin) - Minimum gingival height – 0.5 mm - Maximum gingival height (for all except Straumann BLX L-Link) – 5.0 mm - Maximum gingival height (for Straumann BLX L-LINK) – 6.0 mm - Maximum angle – 20° All zirconia copings (superstructures) for use with the subject device MIST IC L-LINK abutments will conform to ISO 13356. MIST IC PREFIT abutments are cylindrical abutments designed for patient-specific abutment fabrication by a CAD-CAM process and machined into a one-piece, all titanium abutment. The portion of the abutment available for milling is either 9.9 mm in diameter by 20 mm in length or 13.9 mm in diameter by 20 mm in length. MIST IC PREFIT abutments have an engaging connection. The design parameters for PREFIT patient-specific abutments are: - Minimum wall thickness – 0.5 mm - Minimum cementable post height for single-unit restoration – 4.0 (minimum cementable post height for single-unit restoration is defined as the height above the restorative margin) - Minimum gingival height – 0.5 mm - Maximum gingival height (for all except Straumann BLX PREFIT) – 5.0 mm - Maximum gingival height (for Straumann BLX PREFIT) – 6.0 mm - Maximum angle – 30°

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: Compatible Implant Systems | Implant Body Diameter, mm | Implant Platform, mm ---|---|--- Biomet 3i OSSEOTITE® Certain® | 3.25 | 3.4 | 4.0 | 4.1 | 5.0 | 5.0 | 6.0 | 6.0 NobelActive® (conical connection) | 3.5 | 3.5 (NP) | 4.3, 5.0 | 3.9 (RP) | 5.5 | 5.1 (WP) NobelReplace Conical Connection | 3.5 | 3.5 (NP) | 4.3, 5.0 | 3.9 (RP) NobelParallel Conical Connection | 3.75 | 3.5 (NP) | 4.3, 5.0 | 3.9 (RP) | 5.5 | 5.1 (WP) Replace Select Tapered TiUnite | 3.5 | 3.5 (NP) | 4.3 | 4.3 (RP) | 5.0 | 5.0 (WP) | 6.0 | 6.0 Replace Select Tapered PMC | 3.5 | 3.5 (NP) | 4.3 | 4.3 (RP) | 5.0 | 5.0 (WP) | 6.0 | 6.0 Replace Select TC | 3.5 | 3.5 (NP) | 4.0 | 4.3 (RP) Zimmer Screw-Vent® | 3.7 | 3.5 | 4.7 | 4.5 Zimmer Tapered Screw-Vent® | 3.7, 4.1 | 3.5 | 4.7 | 4.5 | 6.0 | 5.7 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 for Biomet 3i Certain 3.25 mm implant bodies are indicated for maxillary lateral and mandbular central/lateral incisors only.

MIST IC from Imagine Milling Technologies, LLC is a line of Ti-base and machinable blank abutments to interface with compatible dental implants from 3 manufacturers, a total of 14 implant-abutment interface compatibilities. The compatible implant body diameters range from 3.25 mm to 6.0 mm and the corresponding implant platform diameters range from 3.4 mm. The subject device prosthetic platform diameters range from 3.8 mm. All stock subject device components (abutments and abutment screws) are made of titanium alloy conforming to ASTM F136. The subject device MIST IC L-LINK abutments have a TiN coating achieved through a physical vapor deposition (PVD) process that is identical to the process used for TiN coating of Imagine Milling Technologies, LLC devices cleared in K 182246. The PVD cathodic arc evaporation process is a high current, low voltage process in which material evaporated from the cathode (Ti) is ionized, transported through the vacuum chamber with reactive gas (N2) and deposited as a non-porous, thin film on the titanium substrate. Each abutment is supplied with the non-sterile abutment screw designed for attachment to the corresponding compatible OEM implant. All patient-specific abutment fabrication for all MIST IC abutments is by prescription on the order of the clinician. All MIST IC abutments are intended to be milled at an Imagine Milling Technologies, LLC validated milling center under FDA quality system regulations. MIST IC L-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 two-piece abutment; the assembly becoming a final finished medical device after cementation on the subject device abutment. They are provided in straight designs, with engaging and non-engaging connections. The L-LNK abutments and corresponding zirconia superstructure are provided to the clinician either with the superstructure cemented to the abutment by the dental laboratory, or separately for the clinician to bond together chairside using the cement recommended in the labeling (RelyX RMGIP bonding cement, cleared in K022476). 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 Minimum gingival height of the coping - 0 mm (all L-LINK bases have minimum gingival height of 0.5 mm) Maximum gingival height – 5.0 mm Maximum angle - 20° All zirconia copings (superstructures) for use with the subject device MIST IC L-LINK abutments will conform to ISO 13356. MIST IC PREFIT abutments are cylindrical abutments designed for patient-specific abutment fabrication by a CAD-CAM process and machined into a one-piece, all titanium abutment. The portion of the abutment available for milling is either 9.9 mm in diameter by 20 mm in diameter by 20 mm in diameter by 20 mm in length. MIST IC PREFIT abutments have an engaging connection. 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 Minimum gingival height - 0.5 mm Maximum gingival height - 5.0 mm Maximum angle - 30°

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.