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Inclusive® Titanium Abutments are premanufactured prosthetic components connected to endosseous dental implants in edentulous or partially edentulous maxilla or mandible to provide support for cement-retained prosthetic restorations. All digitally designed abutments for use with Inclusive® Titanium Abutments for CAD/CAM are intended to be sent to a Prismatik Dentalcraft validated milling center for manufacture.

Compatible Implant System: Neoss® ProActive® Narrow, Neoss® ProActive® Standard, MIS® SEVEN®, Zimmer® Eztetic®

Inclusive® Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. Inclusive® Titanium Abutments are designed and fabricated to be compatible with Neoss® ProActive® Narrow Implant System, Neoss® ProActive® Standard Implant System, MIS® SEVEN® Implant System, and Zimmer® Eztetic® Implant System. The products are made from titanium alloy Ti-6A1-4V ELI, which meets ASTM standard F136. They include Inclusive® Titanium Abutment Blanks intended to be used to fabricate one-piece, all-titanium, patient-specific abutments using CAD/CAM technology and Inclusive® Titanium Abutments 4.5mmH intended to be used for support of fabricated crowns/bridges or a zirconia coping to complete the two-piece abutment. Inclusive® Titanium Abutments are a two-piece abutment with a titanium base and a ceramic top-half which when cemented together (Shofu MonoCem K020481) constitutes the final finished abutment. Each patient-specific abutment is prescribed by a clinician and manufactured by an authorized milling center validated by Prismatik Dentalcraft Inc. Inclusive® Titanium Abutments are provided non-sterile and intended for single use and prescription use.

Inclusive® Multi-Unit Coping is manufactured from titanium alloy, Ti-6A1-4V ELI conforming to ASTM F136 and used in conjunction with the Neoss® ProActive® Standard and MIS® SEVEN® multi-unit abutment. Inclusive® Multi-Unit Coping is bonded with the dental restoration prior to being seated on the multi-unit abutment via a multi-unit prosthetic screw. The non-engaging configuration of the multi-unit coping does not have an internal connection feature and seats onto the flat mating surface of the multi-unit abutment. The multi-unit coping is used in combination with screw-retained multi-unit dental prosthetics, e.g. bridges and bars, which are used to reconstruct the function and aesthetics of lost teeth. The multi-unit coping is straight with no angle correction and provided non-sterile. The device is intended for singe use and prescription use.

This document is a 510(k) premarket notification for Inclusive® Titanium Abutments. It describes the device, its intended use, and provides a comparison to a predicate device to demonstrate substantial equivalence, rather than standalone performance criteria. Therefore, the information typically requested in your prompt regarding acceptance criteria and a study proving device meeting those criteria (especially for AI/software devices) is not directly applicable to this submission.

This is a submission for a physical medical device (dental abutments), and the "acceptance criteria" here refer to demonstrating substantial equivalence to a legally marketed predicate device, rather than the performance metrics of a diagnostic or AI algorithm.

However, I can extract the relevant information regarding the performance data and the aspects that were tested to demonstrate substantial equivalence, which serves a similar purpose in this context:

Summary of Performance Data (to demonstrate Substantial Equivalence):

Additional Information based on the provided text:

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

   • Biocompatibility: The text does not specify a separate "test set" sample size for dedicated biocompatibility testing on this specific device, as it leverages existing data. It states, "additional biocompatibility testing was not conducted" due to identical materials, manufacturing, and facility as the predicate (K191222) and reference device (K160979). Cytotoxicity testing (ISO 10993-5) was referenced from K160979.
   • Mechanical Properties: The document states that static load and fatigue testing was performed "with the worst-case scenario." It does not specify the number of samples tested for this specific submission, but it would have been a sufficient number to meet the requirements of ISO 14801:2016. Data provenance is implied to be internal testing by Prismatik Dentalcraft, Inc.
   • Sterilization: No sample size is specified, as "additional sterilization was not conducted" for this submission due to identical materials, manufacturing, and parameters as predicate and reference devices. Validation was referenced from K083192 and K160979.
   • Packaging: "A packaging validation according to ASTM D4169-16 was conducted" but no specific sample size is mentioned.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a physical device submission relying on established engineering standards and material properties, not an AI or diagnostic device that requires expert-established ground truth for its performance assessment.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for a physical device submission for dental abutments.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This pertains to AI/software performance, not a physical dental implant component.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This pertains to AI/software performance.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • "Ground truth" in this context is based on established engineering standards (e.g., ISO 14801:2016 for dynamic loading, ISO 10993-1 for biocompatibility, ISO 17665-1/2 for sterilization, ASTM D4169-16 for packaging), material specifications (e.g., ASTM F136 for Ti-6Al-4V ELI), and dimensional analysis / reverse engineering for compatibility with OEM implant systems. Biocompatibility also referenced cytotoxicity testing (ISO 10993-5) from a previous submission.

7. The sample size for the training set: Not applicable. This is not an AI/machine learning device.

8. How the ground truth for the training set was established: Not applicable. This is not an AI/machine learning device.

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