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510(k) Data Aggregation
(526 days)
Talladium abutments are used in connection with the prosthetic restoration of dental implants. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns and bridges. The Talladium abutments fit implants with external hexagon, conical, conical, and other internal (e.g., multi-lobed) implants. A dynamic abutment is available to correct the angulation of an implants. . the the angulation of the dynamic abutments to 20° off of the long axis of the inplant).
The Talladium abutments have been tested with the following implant systems:
- Group 1, External Hexagon Abutments: 31 Implant Innovations, Biomet .
- . Group 2, Conical Abutments: Nobel Biocare Multi-Unit
- . Group 3, Internal Conical Abutments: Zimmer Screw-Vent SD
- Group 4, Internal Abutments: Nobel Biocare Replace RP .
Talladium abutments are compatible with the following implants:
3 i Implant Innovations Biomet, Innova, Life-Core, Nobel Biocare, Implamed, Zimmer, IMZ, Bti, Klockner external hexagon implants; Straumann and Nobel Biocare conical implants; Inc., Inc., Inc., Zimmer, BioHorizons and Blue Sky Bio internal hexagonal implants; and Nobel Biocare and Blue Sky Bio Trilobe platform internal connections.
The Talladium abutments are an artificial tooth abutment designed to fit and function on root-form endosseous implants having various abutment interfaces: an external hexagon. conical, internal conical, and other internal connections such as multi-lobed. Talladium also has a dynamic abutment to correct the angulation of an implant if necessary.
Talladium's abutments are intended for use in the treatment of partially edentulous patients in order to restore chewing function. The Talladium abutments are prosthetic abutments that fit a variety of endosseous implants listed below. Talladium's abutments are made from tilite, a biocompatible Base Metal Alloy material that is used in dental restorations.
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and the study that proves the device meets those criteria:
Acceptance Criteria and Device Performance Study for Talladium International Implantology Abutments (K090081)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Fatigue Resistance (Dynamic Tests) | "All testing passed the acceptance criteria" (referencing ISO 14801:2007 for dynamic fatigue testing). This indicates mechanical integrity under cyclic loading. |
| Static Compression Bending | "All testing passed the acceptance criteria." This indicates the device's ability to withstand static loads without failure. | |
| Biocompatibility | Particulate Formation (Wear) | "SEM testing showed negligible to moderate wear, and wear was comparable or less severe than in similar studies." This indicates that the device does not generate excessive or harmful wear particles. |
| Material Biocompatibility | The device is made from "tilite [a] biocompatible Base Metal Alloy material that is used in dental restorations." The 510(k) states that the biocompatibility of this material has "previously been cleared by FDA for use in fixed prosthodontic devices with tissue contact similar to that of the Talladium abutments." This implies that the material itself meets established biocompatibility standards. | |
| Functional Compatibility | Fit with various implant systems | The abutments are "designed to fit and function on root-form endosseous implants having various abutment interfaces: an external hexagon, conical, internal conical, and other internal connections." The devices were tested with specific implant systems (3i Implant Innovations, Biomet, Nobel Biocare Multi-Unit, Zimmer Screw-Vent SD, Nobel Biocare Replace RP) and declared compatible with a wider range of implants (detailed in "Talladium abutments are compatible with the following implants" section). This demonstrates functional fit. |
| Angulation Correction (Dynamic Abutment) | Limit of angulation correction | The dynamic abutment is designed "to correct the angulation of an implant if necessary (limiting the angulation of the dynamic abutments to 20° off of the long axis of the implant)." While the performance section states that all testing passed acceptance criteria, it doesn't explicitly detail the test results verifying this 20-degree limit for the dynamic abutment, but it's an inherent design specification that is implied to be met by the overall "all testing passed" statement. The study included the dynamic abutment, suggesting its specific performance was assessed. |
| Regulatory Compliance | Adherence to relevant standards and guidance documents | "The Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments; Guidance for Industry and FDA Staff (May 12, 2004) was followed as applicable to this submission." Also, "Performance (fatigue) testing according to ISO 14801:2007 has ensured the appropriate design of the Talladium devices." This indicates compliance with recognized standards and FDA guidance for this device type. |
| Substantial Equivalence | Equivalence to predicate devices in intended use, design, and performance | The document explicitly states: "The Talladium Abutments are substantially equivalent in terms of intended use, design, and performance to the predicate devices... nonclinical performance testing (fatigue testing and biocompatibility) was used to validate that performance was acceptable for intended use. Taken together, these factors support the substantial equivalence of Talladium abutments to the predicate devices." The detailed Substantial Equivalence Table further highlights similarities in shape, design, and use, and addresses differences (e.g., material not known for predicates, or different materials) by referencing the successful fatigue and biocompatibility testing of the Talladium abutments. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: The document mentions that static and dynamic tests were performed for "four dental abutment and implant systems, one (the most susceptible) for each type of connection, including the dynamic abutment." This implies a small sample size of at least four representative systems, however, the exact number of individual abutments or tests conducted within each system is not specified.
- Data Provenance: The data is generated from non-clinical (laboratory) performance testing conducted by the manufacturer, Talladium España (Lleida, Spain). The origin is therefore prospective as it was specifically performed for this regulatory submission. There is no mention of patient data, retrospective studies, or data from specific countries of origin related to patient outcomes.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
There were no human experts involved in establishing ground truth for this type of performance testing. The "ground truth" for the mechanical and material performance of these dental abutments is established by objective engineering standards and laboratory measurements as defined by ISO 14801:2007 and general biocompatibility principles for medical devices. The interpretation of these results would typically be done by engineers and material scientists.
4. Adjudication Method for the Test Set
Not applicable. As described above, the "truth" is determined by objective physical and chemical testing against established standards, not by human interpretation requiring adjudication.
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
No, an MRMC comparative effectiveness study was not done. This device is a dental implant abutment, not an AI-based diagnostic or therapeutic device that would involve human readers or AI assistance in interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device is a physical medical device, not a software algorithm.
7. The Type of Ground Truth Used
The ground truth used for this study is based on:
- Objective performance standards: Specifically, the requirements and methodologies outlined in ISO 14801:2007 for dynamic fatigue testing, and general principles for static mechanical testing.
- Material science principles and established biocompatibility: The assessment of wear particles via SEM and the historical FDA clearance of the "tilite" material.
- Engineering design specifications: For example, the 20° angulation limit for the dynamic abutment.
8. The Sample Size for the Training Set
Not applicable. This device does not use an "AI algorithm" that requires a training set. The "training" for this physical device comes from established engineering design principles, manufacturing processes, and material science knowledge.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of an AI algorithm. The performance is assessed against pre-defined engineering and material standards, not learned from a dataset.
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