(99 days)
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.
The provided document is a 510(k) summary for a dental implant abutment system named "Sherlock" (K212664). It details the device's technical specifications and compares it to predicate and reference devices to demonstrate substantial equivalence.
However, the document does NOT contain information about an AI/ML-based device or a study proving its performance against acceptance criteria using clinical data, reader studies, ground truth establishment, or sample sizes for AI training/testing. The "Performance Data" section explicitly states: "No animal or clinical data is included in this premarket notification." The tests performed are non-clinical, focusing on biocompatibility, reverse engineering for compatibility, and static compression fatigue.
Therefore, I cannot provide the requested information for an AI/ML device study. The content of the document pertains to the regulatory clearance of a physical medical device (dental abutments) based on substantial equivalence to existing devices, primarily through non-clinical performance data.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)