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Sherlock abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations. All digitally designed CAD/CAM customizations for Sherlock abutments are to be sent to an Open Implants-validated milling center for manufacture. Sherlock abutments are compatible with the implant systems listed in the Compatibility Table: **Compatibility Table** | Compatible Implant Systems | Implant Body Diameter (mm) | Implant Platform Diameter (mm) | |---|---|---| | Neodent Helix GM®, Drive GM®, Titamax GM® | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | 3.0 |

Sherlock is a dental implant abutment system that is being expanded to include a new compatible implant system, Neodent GM®. The Subject device implant platform diameter is 3.0 mm, and the corresponding compatible implant body diameters range from 3.5 mm to 7.0 mm. The abutment designs are Titanium Base, Titanium Blank, Straight Multi-Unit, Multi-Unit Angled 17°, and Multi-Unit Angled 30° Abutments. These abutment designs were previously cleared in the sponsor's K220482 Predicate device and K212664 Reference device submissions. All abutment designs are provided with corresponding abutment screws. The Subject device Titanium Base abutments are intended to be used as a two-piece abutment composed of the base bottom-portion (prefabricated titanium base component) with a cemented/bonded CAD-CAM fabricated zirconia top-portion (superstructure) where the final two-piece abutment (base component and cemented superstructure) is the finished device used for the prosthetic restoration. Each patient-specific zirconia superstructure is individually prescribed by the clinician and manufactured by an authorized milling center. All Subject device prefabricated titanium base components are provided in a straight design with no angulation in the titanium base post. They are provided with either an indexed/engaging implant connection for crowns or a non-engaging/nonindexed implant connections for bridges. The standard prefabricated titanium base components are provided in gingival heights ranging from 0.8 mm to 3.0 mm and abutment post lengths of 8 mm or 10 mm. The ASC prefabricated titanium base components are provided in gingival heights ranging 0.8 mm to 2.5 mm and abutment post length of 8 mm. Additional gingival height may be provided for both abutment designs in the zirconia superstructure. ASC prefabricated titanium base components are provided with a cutout in the prosthetic post to accommodate a restoration with an angled screw channel when clinically necessary. Standard prefabricated titanium base components and ASC prefabricated titanium base components posts may be reduced to 4 mm to accommodate individual patient occlusion. The zirconia mesostructure may contain an angled post within the established design parameters. The overall design parameters for the two-part Standard and ASC CAD/CAM prefabricated titanium base components with zirconia mesostructure are: - Minimum Zirconia Wall Thickness – 0.5 mm - Minimum Post Height for single-unit abutment* – 4.0 mm - Minimum Overall Gingival Height – 0.8 mm (titanium base plus zirconia) - Maximum Overall Gingival Height – 5 mm - Maximum Correction Angle – 30° The required cement for bonding the zirconia superstructure to the Subject device Titanium Bases to create the final two-piece abutment is Kuraray Noritake Dental PANAVIA™ V5 cleared in K150704. Titanium Blank abutments, sometimes referred to as "Pre-mill" or "Ti-Blank" abutments are one-part abutments intended for use in a CAD/CAM workflow. Each Subject device Titanium Blank implant abutment has a pre-manufactured indexed implant connection interface with a cylindrical customization section and a milling retention geometry section. The retention geometry holds the component in a milling machine fixture while the patient-specific portion above the implant interface is milled in a dental milling machine. All patient-specific Titanium Blank abutment fabrication is by prescription on the order of the clinician. The overall design parameters for the Titanium Blank customized abutments are: - Minimum Wall Thickness – 0.75 mm - Minimum Post Height for single-unit abutment* – 4.0 mm - Minimum Overall Gingival Height – 0.8 mm - Maximum Overall Gingival Height – 5 mm - Maximum Correction Angle – 30° All digitally designed zirconia mesostructures for use with the Subject device titanium base abutments and digitally designed Subject device titanium blank abutments will be fabricated at an Open Implants validated milling center under FDA quality system regulations. Multi-Unit Abutments (MUAs) are intended for use with multi-unit restorations. They are considered two-part abutments. The base portion of the MUA is connected directly to the implant either with an integral screw (straight MUA) or with a separate multi-unit abutment screw (angulated abutments). Straight MUAs have a non-indexed connection with the dental implant. The angulated MUAs have an indexed connection with the dental implant. The second part of the MUA is a mating coping which is retained with a prosthetic screw. Multi-Unit Abutments are available in Straight, 17° Angulated and 30° Angulated configurations. The coping and prosthetic screw is compatible with each MUA design/configuration. All Subject device abutments and corresponding abutment screws are pre-manufactured from Ti-6Al-4V ELI (Grade 23) titanium conforming to ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) and are provided non-sterile to the user. The mesostructure/copings for Titanium base abutments are fabricated from zirconia conforming to ISO 13356, Implants for surgery — Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP).

Sherlock abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations. All digitally designed CAD/CAM customizations for Sherlock abutments are to be sent to an Open Implants-validated milling center for manufacture. Sherlock abutments are compatible with the implant systems listed in the Compatibility Table: | Compatible Implant Systems | Implant Body Diameter (mm) | Implant Platform Diameter (mm) | |----------------------------|----------------------------|--------------------------------| | Nobel Biocare NobelActive® | 3.5 | 3.5 (NP) | | Nobel Biocare NobelActive® | 4.3, 5.0 | 3.9 (RP) | | Straumann Bone Level | 3.3 | 3.3 (NC) | | Straumann Bone Level | 4.1, 4.8 | 4.1, 4.8 (RC) | | Zimmer TSV | 3.7, 4.1 | 3.5 | | Zimmer TSV | 4.7 | 4.5 | | Zimmer TSV | 6.0 | 5.7 |

Sherlock is a dental implant abutment system that is being expanded to include two (2) new abutment designs compatible with three (3) OEM implant systems. The Subject device implant platform diameters range from 3.3 mm to 5.7 mm, and the corresponding compatible implant body diameters also range from 3.3 mm. The Subject device includes the following two-piece abutment designs: Titanium Base with angulated screw channel (ASC) and are provided with corresponding abutments and screws are manufactured from Ti-6Al-4V ELI alloy conforming to ASTM F136 and are provided non-sterile. In final, finished form, the Subject device abutments are intended to be used as a two-piece abutment composed of the base bottom-portion (titanium base) with a cemented/bonded CAD-CAM zirconia top-portion. Each patientspecific zirconia superstructure is individually prescribed by the clinician and manufactured milling center. All Subject device abutments are provided in a straight design with no angulation in the titanium base post and with an indexed/engaging implant connection for crowns or a non-engaging/non-indexed implant connections for bridges. The standard Titanium base abutments are provided in gingival heights ranging from 0.25 mm and abutment post lengths of 8 mm or 10 mm. The ASC Titanium Base abutments are provided in gingival heights ranging 0.8 mm to 1.8 mm and abutment post length of 8 mm. Additional gingival height may be provided for both abutment designs in the zirconia superstructure. ASC Titanium Base abutments are provided with a cutout in the prosthetic post to accommodate a restoration with an angled screw channel when clinically necessary. Standard Titanium Base and ASC Titanium Base posts may be reduced to 4 mm to accommodate individual patient occlusion. The zirconia mesostructure may contain an angled post within the established design parameters. All digitally designed zirconia copings (mesostructures) for use with the Subject device titanium base abutments will be made at an Open Implants validated milling center under FDA quality system regulations, and the zirconia material will conform to ISO 13356. The overall design parameters for the two-part Standard and ASC CAD/CAM Titanium Base customized abutments with zirconia mesostructure are: Minimum Zirconia Wall Thickness – 0.5 mm Minimum Post Height for single-unit restoration – 4.0 mm for Straumann implant line Minimum Overall Gingival Height – 0.5 mm (titanium base plus zirconia) Maximum Overall Gingival Height – 5 mm Maximum Correction Angle - 30° The recommended cement for bonding the zirconia superstructure to the Subject device Titanium Bases to create the final two-piece abutment is Kuraray Noritake Dental PANAVIA™ V5 cleared in K150704.

Sherlock abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations. All digitally designed CAD/CAM customizations for Sherlock abutments are to be sent to an Open Implants-validated milling center for manufacture. Sherlock abutments are compatible with the implant systems listed in the Compatibility Table: | Compatible Implant Systems | Implant Body Diameter (mm) | Implant Platform Diameter (mm) | |----------------------------|----------------------------|--------------------------------| | Biomet 3i Certain | 3.25 | 3.4 | | | 4.0 | 4.1 | | | 5.0 | 5.0 | | | 6.0 | 6.0 | | Straumann Bone Level | 3.3 | 3.3 (NC) | | | 4.1, 4.8 | 4.1, 4.8 (RC) | | Zimmer TSV | 3.7, 4.1 | 3.5 | | | 4.7 | 4.5 | | | 6.0 | 5.7 |

Sherlock is a dental implant abutment system that includes four (4) abutment designs compatible with three (3) OEM implant systems. The Subject device abutment platform diameters range from 3.0 mm to 6.5 mm, and the corresponding compatible implant body diameters also range from 3.0 mm to 6.5 mm. The subject device includes the following abutment designs: Titanium blank, multi-unit angled 17°, and multiunit angled 30°. The system also includes corresponding abutment screws. All abutments and screws are manufactured from Ti-6Al-4V alloy conforming to ASTM F136 and are provided nonsterile to the end user. All digitally designed customized Titanium Blank abutments are to an Open Implants-validated milling center for manufacture. The design parameters for the CAD/CAM Titanium Blank custom abutment are: Minimum wall thickness – 0.41 to 1.6 mm (varies by implant line); Minimum post height for single-unit restoration - 4.0 mm; Maximum Correction Angle - 30°; Minimum gingival height - 0.5 mm to 0.8 mm (varies by implant line); Maximum gingival height - 5 mm.

Sherlock abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations. All digitally designed CAD/CAM customizations for Sherlock abutments are to be sent to an Open Implants-validated milling center for manufacture. Sherlock abutments are compatible with the implant systems listed in the Compatibility Table: Compatibility Table Compatible Implant Systems | Implant Body Diameter (mm) | Restorative Platform Diameter (mm) ----------------------------|----------------------------|------------------------------------ NobelActive® | 3.5 | 3.5 (NP) | 4.3, 5.0 | 3.9 (RP)

Open Implants' Sherlock abutments are a system of dental implant abutments which have an implant /abutment interface design compatible with the OEM Nobel Biocare NobelActive implant system. Each Subject device implant abutment has a pre-manufactured implant connection interface. The implant body diameters are 3.5 mm with a restorative diameter of 3.5 mm (NP), 4.3 and 5.0 mm with a restorative diameter of 3.9 mm (RP). The Subject device abutments, multi-unit sleeves and corresponding abutment screws are all premanufactured from Ti-6Al-4V ELI (Grade 23) titanium conforming to ASTM F136 and provided nonsterile to the user. Subject device abutments are available in two configurations; a customizable titanium blank abutment, and a multi-unit abutment. The titanium blank abutments are intended to be customized by means of CAD/CAM technology to provide basis or support for single or multiple tooth prosthetic restorations. All digitally designed customized abutments from titanium blank abutments are to an Open Implant-validated milling center for manufacture. The Multi-unit abutments are intended to provide support for multiple tooth bridge supported prosthetic restorations. Multi-unit Temporary Cylinders are intended to be used to fabricate temporary multi-unit prosthetic restorations. The temporary cylinder and associated prosthetic restoration have a maximum intended use of six months.