(86 days)
s-Clean Link Abutment Narrow is intended for use with dental implant as a support for single or multiple tooth prostheses in mandibular central and lateral incisors and maxillary lateral incisors.
s-Clean Link Abutment Narrow is intended for use with the s-Clean OneQ-SL Narrow Fixture according to connector part in the chart. All digitally designed zirconia for use with s-Clean Link Abutment Narrow are intended to be manufactured at a Dentis validated milling center.
The s-Clean Link Abutment Narrow is intended to provide support for customized prosthetic restorations such as crowns and bridges. The s-Clean Link Abutment is composed of a two-piece abutment that is a link abutment at the bottom and a coping (CAD/CAM patient specific superstructure) as the top-half. The submission also includes an abutment fixation screw. The s-Clean Link Abutment are pre-manufactured (stock) abutments, made from a titanium alloy conforming to ASTM F136.
The top half of the s-Clean link abutment composed of zirconia is referenced from our previously cleared K222913 submission.
s-Clean Abutment Screw is made of Ti-6Al-4V ELI (ASTM F136) and cleared in K161244.
The diameters of s-Clean Link Abutment Narrow are 4.0 and 4.5mm.
s-Clean Link Abutment Narrow is provided non-sterile and must be sterilized after the cementation of the patientspecific superstructure on the Link Abutment Narrow.
Accessing the provided text, there is no information about an AI/ML device, its acceptance criteria, or a study proving that it meets those criteria. The document describes a traditional medical device, specifically a dental implant abutment (s-Clean Link Abutment Narrow), and its 510(k) clearance process.
Therefore, I cannot provide the requested information. The text does not contain details regarding:
- A table of acceptance criteria and reported device performance for an AI/ML device.
- Sample sizes or data provenance for an AI/ML test set.
- The number or qualifications of experts for establishing ground truth for an AI/ML device.
- Adjudication methods for an AI/ML test set.
- A multi-reader multi-case (MRMC) comparative effectiveness study for AI assistance.
- Stand-alone performance of an AI algorithm.
- The type of ground truth used for an AI/ML device.
- The sample size for an AI/ML training set.
- How ground truth for an AI/ML training set was established.
The document focuses on non-clinical testing for equivalence to a predicate device, material testing, sterilization validation, biocompatibility, and MRI compatibility for a physical dental implant component.
§ 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.)