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510(k) Data Aggregation
(211 days)
MULTI- UNIT ABUTMENTS FOR STRAUMANN AND ASTRA TECH IMPLANT SYSTEMS
The Multi-Unit Abutments for Straumann and Astra Tech Implant Systems are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.
Nobel Biocare's Multi-Unit Abutments for Straumann and AstraTech Implant Systems are endosseous dental implant abutments. The Nobel Biocare Multi-Unit Abutments for Straumann and AstraTech Implant Systems attach directly to endosseous dental implants and provides a platform for restoration.
Nobel Biocare's Multi-Unit Abutments for Straumann and AstraTech Implant Systems are made entirely of titanium/vanadium alloy.
This document is a 510(k) Summary of Safety and Effectiveness for Nobel Biocare's Multi-Unit Abutments for Straumann and AstraTech Implant Systems. This device is an endosseous dental implant abutment. The submission demonstrates substantial equivalence to previously cleared devices.
Here's the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Set by FDA Guidance) | Reported Device Performance |
|---|---|
| Fatigue testing in accordance with the FDA guidance Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments. The testing must indicate that the abutments are substantially equivalent to the identified predicates. | Worst-case test samples were subjected to fatigue testing. The testing indicates that the abutments are substantially equivalent to the identified predicates. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a numerical sample size for the test set. It mentions "worst-case test samples" were identified and tested. The data provenance is within a laboratory setting, as it refers to "fatigue testing" of the physical devices. No country of origin for the data is explicitly stated beyond Nobel Biocare USA LLC's address in California. The study is prospective in the sense that the testing was performed on the new device to demonstrate its equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This is a submission for a physical medical device (dental implant abutment) that undergoes mechanical and material testing, not a diagnostic or AI-driven device requiring expert-established ground truth. The "ground truth" for this type of device is compliance with specific mechanical and material standards as outlined in FDA guidance documents.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this is mechanical testing of a physical device against established standards, not a diagnostic or AI study requiring adjudication of interpretations.
5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-reader Multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of medical images, often with AI assistance. This submission is for a physical dental implant abutment.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
The "ground truth" for this device's safety and effectiveness is established by physical standards and performance requirements for endosseous dental implant abutments, as outlined in the "FDA guidance Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." This involves demonstrating mechanical properties (like fatigue strength) are equivalent to legally marketed predicate devices.
8. The Sample Size for the Training Set
Not applicable. As this is not an AI or machine learning device, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Summary of the Study:
The study conducted was a fatigue testing of "worst-case test samples" of the Multi-Unit Abutments for Straumann and AstraTech Implant Systems. The objective was to demonstrate that these abutments meet the safety and effectiveness requirements by being substantially equivalent to legally marketed predicate devices (listed in the "Legally Marketed Device(s)" section of the document). The criteria for "substantial equivalence" were based on the FDA's Class II Special Controls Guidance Document for Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, which sets out performance standards, particularly related to fatigue life. The testing results indicated that the new device met these criteria, thereby proving its substantial equivalence to the predicates.
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