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The Straumann® Variobase® Abutment is a titanium base placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® Abutments are indicated for screwretained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Straumann® Variobase® Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.

The purpose of the subject submission is to add the previously cleared Straumann n!ce glass ceramic material (K160262) as a cleared material suitable for fabrication of the coping or crown that, when bonded to the previously cleared Variobase abutment base (K142890), forms a finished dental prosthesis. The Straumann Variobase Abutments are pre-manufactured (stock) abutments, sometimes referred to as "Ti-bases". Straumann Variobase Abutments are available to fit Straumann dental implant platforms NNC (Narrow Neck CrossFit®), RN (Regular Neck), WN (Wide Neck), NC (Narrow CrossFit), and RC (Regular CrossFit). A dental laboratory technician would design the corresponding coping and/or crown (the second component of the Variobase two-piece abutment) and/or prosthetic restoration in the dental laboratory via their preferred workflow. The coping and/or crown would be manufactured via traditional laboratory methods for pressing or casting, or via validated Straumann milling.

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The Straumann® Variobase Abutment is a titanium base placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® Abutments are indicated for screwretained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Straumann® Variobase® Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.

The purpose of the subject submission is to add the zerion® ML and zerion® UTML Zirconia ceramic materials as a material suitable for fabrication of the coping, crown or bridge that, when bonded to the previously cleared Variobase abutment base (K120822, K142890), forms a finished dental prosthesis. The Straumann Variobase Abutments are pre-manufactured (stock) abutments, sometimes referred to as "Ti-bases". Straumann Variobase Abutments are available to fit Straumann dental implant platforms NNC (Narrow Neck CrossFit®), RN (Regular Neck), WN (Wide Neck), NC (Narrow CrossFit), and RC (Regular CrossFit). A dental laboratory technician would design the corresponding coping and/or crown (the second component of the Variobase two-piece abutment) and/or prosthetic restoration in the dental laboratory via their preferred workflow. The restoration will be manufactured via validated Straumann milling.

The provided document is a 510(k) summary for the Straumann® Variobase® Abutments, an endosseous dental implant abutment. The primary purpose of this submission is to add new Zirconia ceramic materials (zerion® ML and zerion® UTML Zirconia) as suitable materials for fabricating the coping, crown, or bridge that attach to the Variobase abutment base.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines performance data related to the physical and biological characteristics of the device rather than traditional clinical performance (e.g., diagnostic accuracy metrics like sensitivity, specificity, AUC). The acceptance criteria are based on compliance with established standards and guidance documents.

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

• Sample Size: The document does not specify exact sample sizes for each bench test (e.g., number of abutments for fatigue testing, number of samples for cytotoxicity). It only states that "Bench testing was performed."
• Data Provenance: All testing appears to be retrospective bench testing conducted in vitro (laboratory setting) and pre-clinical. There is no indication of human or animal studies. The country of origin of the data is not explicitly stated but is implied to be conducted by or for Institut Straumann AG, a Swiss company with a US subsidiary.

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

• This information is not applicable in the context of this submission. The "ground truth" for the acceptance criteria mentioned (e.g., material compliance, fatigue limits, sterility, biocompatibility) is established by international standards (ISO) and FDA guidance documents, not by individual experts establishing a "ground truth" on a test set in the same way an expert would for a diagnostic AI device. The tests themselves are designed to measure against these established benchmarks.

4. Adjudication Method for the Test Set:

• This information is not applicable. Since the "ground truth" is based on objective standards and measurement rather than expert interpretation of complex data (like medical images), there is no need for an adjudication method among experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, an MRMC comparative effectiveness study was not done. This type of study assesses reader performance with and without AI assistance for diagnostic tasks. The Straumann® Variobase® Abutments are a physical implant component, not a diagnostic AI device.

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

• No, this is not applicable. The device is a physical medical component, not an AI algorithm. While software validation was performed, it relates to the design and manufacturing software, not a standalone AI diagnostic tool.

7. The Type of Ground Truth Used:

• The "ground truth" for the acceptance criteria is based on established regulatory standards, consensus standards (ISO), and FDA guidance quantitative limits and requirements. For example:
  • Material: ISO 5832-11 for titanium alloys.
  • Dynamic Fatigue: FDA guidance document for Class II Endosseous Dental Implants and Abutments, which sets performance thresholds.
  • Biocompatibility (Cytotoxicity, Extractables): ISO 10993 series standards.
  • Sterilization: ISO 17665 series standards and FDA guidance.
  • Software: FDA guidance and IEC 62304.

8. The Sample Size for the Training Set:

• This information is not applicable. This submission is for a physical medical device, not a machine learning model that requires a training set. The term "training set" is relevant for AI/ML device development.

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

• This information is not applicable for the same reasons as point 8.

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