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The FRIALIT® PLUS Dental Implant System is indicated for use in single tooth restorations, edentulous spans restored with multiple single teeth, freestanding bridges and to retain overdentures. The implants can be used for immediate implant placement, delayed immediate or late implant placement.

The XiVE®S PLUS Dental Implant System is indicated for the following: Once the implant has osseointegrated, it serves to support single tooth, bridge and overdenture restorations. In the edentulous mandible, a minimum of four XiVE® dental implants (≥9.5mm length) are placed between the mental foramina and rigidly splinted together. In this case, bar prosthetic loading is possible immediately after implant placement.

The XiVE® D3.0 PLUS Dental Implant System is indicated for single tooth restorations and splinted tooth restorations in the region of 7 to 10 and 23 to 26.

The XiVE® TG PLUS Dental Implant System is indicated for single-stage implant placement, with a minimum healing phase of three months in good quality bone and four months in spongy bone, for maxillary and mandibular splinted crowns, bridges and bar-retained overdenture restorations. The bridge must be supported by a minimum of two transgingival threaded implants. In the edentulous maxilla, a minimum of four transgingival implants are placed in a trapezoidal distribution and rigidly splinted together. In the edentulous mandible, a minimum of four transgingival implants (≥9.5mm length) are placed between the mental foramina and rigidly splinted together. In this case, bar prosthetic loading is possible immediately after implant placement.

Device Description

The FRIALIT®, XiVE® and XiVE® TG dental implants with the new FRIADENT Surface have been cleared for commercial distribution. The purpose of this application is to change the name of the surface to PLUS and obtain clearance for additional marketing claims associated with the PLUS surface.

AI/ML Overview

This 510(k) summary describes a modification to an existing dental implant system, specifically changing the surface name to "PLUS" and seeking clearance for associated marketing claims. As such, the submission focuses on demonstrating substantial equivalence to previously cleared devices rather than establishing de novo performance criteria against acceptance thresholds.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (As Implied by Substantial Equivalence and Preclinical/Animal Studies)	Reported Device Performance
Biocompatibility/Surface Characteristics	The "PLUS" surface should exhibit favorable physiochemical surface characteristics and support osseointegration comparable to or better than existing FRIADENT surfaces and other commercially available surfaces.	Preclinical evaluations at the University of Tubingen, Germany, compared physiochemical surface characteristics to other commercially available surfaces. Animal studies (University of Cologne, Germany; University of São Paulo, Brazil) evaluated loaded and unloaded implants, immediate placement in infected sites, and the effect of laser therapy on osseointegration. Conclusion: "Results of these studies support the PLUS surface characteristics, name and advertising claims for the FRIADENT Dental Implant Systems." Specific mention of "higher removal torque values compared to solely acid-etched implants and anodic oxidized textured implants" after 5 months, interpreted as "an increase in the strength of endosseous implant integration and implant stability."
Mechanical Strength	Maintain mechanical strength comparable to existing FRIADENT dental implant systems.	Stated that the new systems are "substantially equivalent to the current FRIADENT® Dental Implant Systems in terms of... mechanical strength."
Intended Use	The modified devices should remain suitable for their indicated uses (single tooth restorations, bridges, overdentures, various implant placement timelines).	The intended uses for the FRIALIT® PLUS, XiVE® S PLUS, XiVE® D3.0 PLUS, and XiVE® TG PLUS systems are clearly outlined and align with general dental implant applications.
Safety and Effectiveness	The device should be safe and effective for its intended use, demonstrating substantial equivalence to predicate devices.	The submission provides a "Class III certification and summary of adverse safety and effectiveness information pursuant to 513(f) of the Federal Food, Drug, and Cosmetic Act." The overall conclusion is that "Comparison of the FRIADENT dental implant systems to the predicate device shows that the device is substantially equivalent."

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size for Test Set: Not explicitly stated as a number of implants or subjects. The studies were preclinical and animal studies.
Data Provenance:
- Country of Origin: Germany (University of Tubingen, University of Cologne) and Brazil (University of São Paulo).
- Retrospective or Prospective: Not explicitly stated, but preclinical and animal studies are typically prospective in their design.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable in the context of this 510(k) summary. The "ground truth" for these types of studies is derived from objective measurements (physiochemical analysis, biomechanical testing, histological evaluation in animal models) performed by researchers at the respective universities, not through expert consensus on interpretation of images or clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of expert interpretations (e.g., medical imaging). The studies involved laboratory and animal experiments with quantifiable outcomes.

5. 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 submission is for a dental implant system (hardware), not an AI-powered diagnostic or assistive tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an algorithm or software device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" was established through:

Physiochemical surface analyses: Laboratory measurements of surface properties.
Histological and biomechanical analyses in animal models: Evaluation of osseointegration, bone-implant contact, and removal torque values in vivo. This is akin to "pathology" or objective biological outcomes in an animal setting.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-driven device requiring a training set. The studies described are traditional preclinical and animal investigations.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, this is not an AI/ML device.

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