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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

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).

The provided FDA 510(k) Clearance Letter for Sherlock Dental Implant Abutment does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

This document describes the device's indications for use, its substantial equivalence to predicate devices, and the non-clinical data reviewed by the FDA for clearance. However, it does not detail specific acceptance criteria or an associated study demonstrating compliance with those criteria.

The "Performance Data" section lists several types of non-clinical data submitted, such as static and fatigue testing according to ISO 14801, a reverse engineering study, biocompatibility testing, cleaning and sterilization validation, and an MRI review. These are the studies performed to support the substantial equivalence claim, but the FDA letter does not specify quantitative acceptance criteria for these tests nor does it report specific performance outcomes that directly address such criteria.

Therefore, I cannot populate the requested table or provide details for points 1-9 based solely on the provided text. The document focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a performance study against predefined acceptance criteria.

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