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s-Clean Link Abutment is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

s-Clean Link Abutment is intended for use with the Dentis s-Clean s-Line and Dentis s-Clean s-Line Mini according to connector part in the chart. All digitally designed zirconia for use with s-Clean Link Abutment are intended to be manufactured at a Dentis validated milling center.

The s-Clean Link Abutment is intended to provide support for customized prosthetic restorations such as crowns and bridges. The s-Clean Link Abutment is composed of two-piece abutment that is a link abutment at the bottom, a coping (CAD/CAM patient specific superstructure) at the top and screw. The bottom link abutment portion of the s-Clean Link Abutment is pre-manufactured (stock) made from a titanium alloy conforming to ASTM F136. The Top half of the s-Clean Link Abutment is composed of zirconia conforming to ISO 6872 reference to prior cleared ceramic, K141724.

s-Clean Abutment Screw s-Line is made of Ti-6AI-4V ELI (ASTM F136)

The diameters of s-Clean Link Abutment are 4.5 and 4.8mm.

s-Clean Link Abutment is provided non-sterile therefore must be sterilized after the cementation of the patientspecific superstructure on the Link Abutment.

The proposed devices are compatible with the following device.

Raw material blanks

• K141724, Upcera Dental Zirconia Blank & Dental Zircornia Pre-Shaded Blank by Liaoning Upcera Co.. Ltd.
  Raw material cement
• K191122, 3M RelyX Pediatric Resin Modified Glass Ionomer Cement by 3M ESPE Dental Product .
  The coping that composes the final abutment should be designed and milled through the CAD/CAM software, according to the prosthetic planning and patient clinical situation. The coping and crowns designed using these or more recent versions of the CAD/CAM System, within the design limits as defined within the design software, are compatible with the link abutment.

The coping would be manufactured by Dentis only with design input using CAD/CAM Software from and by Dentis milling center.

Design Limitation for Superstructure:

| | Zirconia for s-Clean Link Abutment
Regular | Zirconia for s-Clean Link Abutment
Mini |
|-------------------------------------------------------------|-----------------------------------------------|--------------------------------------------|
| Minimum wall thickness | 0.5 | 0.5 |
| Minimum/Maximum Post Height for
single-unit restorations | 4.45 | 4.45 |
| Maximum gingival height in the
zirconia superstructure | 0 | 0 |
| Minimum gingival height in the Link
Abutment | 1 | 1 |
| Maximum angulation | 0 | 0 |

This FDA 510(k) summary focuses on demonstrating substantial equivalence of the s-Clean Link Abutment to a predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria in the context of an AI/ML medical device. The document describes a dental implant abutment, which is a physical device, not an AI/ML algorithm.

Therefore, the requested information regarding AI/ML device performance, such as sample sizes for test/training sets, expert consensus for ground truth, MRMC studies, and human-in-the-loop performance, is not applicable to the provided document.

The document primarily addresses non-clinical testing for a physical medical device. Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present "acceptance criteria" in the typical quantitative performance metrics sense for an AI/ML device (e.g., sensitivity, specificity thresholds). Instead, it demonstrates "substantial equivalence" to a predicate device based on design, materials, indications for use, and non-clinical testing.

The key "performance" is demonstrated through:

2. Sample size used for the test set and the data provenance:

• Test Set (Non-Clinical): Not directly applicable in the terms of a "test set" for an AI/ML algorithm. For the physical device, non-clinical tests (sterilization, biocompatibility, cytotoxicity) were performed. The sample sizes for these specific lab tests are not detailed in this summary document, but standard methods for such tests typically involve a sufficient number of samples to ensure statistical validity for the physical properties being measured.
• Data Provenance: Not applicable as it's not a data-driven AI/ML study. The data provenance would refer to the lab where tests were conducted which is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. Ground truth, in the context of an AI/ML device, is established by expert annotation or clinical outcomes. For this physical dental abutment, "ground truth" is established by manufacturing specifications, material standards, and benchmark testing against established predicate devices and recognized international standards (e.g., ISO, ASTM, AAMI).

4. Adjudication method for the test set:

• Not applicable. This is relevant for clinical studies or expert labeling in AI/ML.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. This is explicitly stated: "Clinical testing was not necessary to establish substantial equivalency of the device." MRMC studies are for assessing diagnostic or clinical performance with human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable. This device is a physical dental implant component, not an algorithm.

7. The type of ground truth used:

• For a physical device, "ground truth" refers to compliance with material specifications (e.g., ASTM F136 for titanium alloy, ISO 6872 for zirconia), design parameters, and the results of standardized non-clinical performance tests (e.g., sterilization effectiveness, biocompatibility). The predicate device (DIO CAD/CAM Abutment, K181037) also serves as a "ground truth" for substantial equivalence comparison.

8. The sample size for the training set:

• Not applicable. There is no "training set" for a physical device.

9. How the ground truth for the training set was established:

• Not applicable. There is no "training set" for a physical device.

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