(80 days)
Dynamic TiBase abutments are intended for use with dental implants as a support for single-unit or multi-unit prostheses in the maxillary or mandibular arch of a partially or fully edentulous patient.
The purpose of this submission is to obtain marketing clearance for Dynamic TiBase, a series of twopiece titanium base abutments that require the fabrication of patient-specific custom superstructures using CAD-CAM technology. In final, finished form, the subject device abutments are intended to be used as a two-piece abutment composed of the base bottom-half (titanium base) with a bonded CAD-CAM zirconia top-half. Each patient-specific zirconia superstructure is individually prescribed by the clinician and manufactured by an authorized milling center.
This document is a 510(k) Premarket Notification for the Talladium España, SL Dynamic TiBase, which is an endosseous dental implant abutment. The primary purpose of this submission is to demonstrate substantial equivalence to legally marketed predicate devices, not to prove clinical effectiveness or safety in the same way clinical trials do. Therefore, the information provided focuses on non-clinical data and comparisons to existing devices, rather than clinical study results with human subjects.
Based on the provided document, here's a breakdown of the acceptance criteria and the study that proves the device meets them, specifically in the context of a 510(k) submission:
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission for a device like this, the "acceptance criteria" are not clinical performance metrics in the traditional sense (e.g., sensitivity, specificity for a diagnostic device). Instead, they revolve around demonstrating substantial equivalence to predicate devices in terms of:
- Intended Use: The device performs the same function for the same patient population.
- Technological Characteristics: The device has similar design, materials, and operating principles.
- Performance (Non-Clinical): The device performs similarly to or better than the predicate in engineering/bench tests relevant to its function and safety. Any differences in technological characteristics must not raise new questions of safety or effectiveness.
The reported device performance is primarily based on non-clinical (bench) testing and comparison tables, not clinical studies in human subjects.
Here's a table summarizing the "acceptance criteria" (or areas of equivalence demonstration) and the reported device performance as per the document:
| Acceptance Criterion (Area of Equivalence) | Reported Device Performance (as demonstrated in 510(k)) |
|---|---|
| Intended Use | Dynamic TiBase abutments are intended for use with dental implants as a support for single-unit or multi-unit prostheses in the maxillary or mandibular arch of a partially or fully edentulous patient. |
| Demonstrated Equivalence: Stated to be substantially equivalent to primary predicate (K202026) and reference devices (K182246, K191919, K162021) in indications for use. Differences in wording do not affect intended use. | |
| Technological Characteristics | Device Type: CAD-CAM Titanium Base Abutments (two-piece, titanium base with bonded CAD-CAM zirconia superstructure). |
| Materials: Titanium alloy (Ti-6Al-4V) conforming to ASTM F136 and ISO 5832-3 for abutments and screws. Zirconia (ISO 13356) for copings. | |
| Design/Features: Straight design, 0.7 mm gingival height, cut-out for angled screw channel, specific post heights. Compatible with Thommen SPI® CONTACT dental implant fixtures. | |
| Biocompatibility | All subject device abutments are biocompatible. |
| Performance: Biocompatibility testing performed according to ISO 10993-12 (referenced) and confirmatory testing for finished devices (ISO 10993-5 and ISO 10993-12) was done. | |
| Sterilization Validation | The device can be effectively sterilized by the end-user. |
| Performance: Moist heat sterilization validation performed according to ISO 17665-1 and ISO 11737-2 (referenced). Device provided non-sterile for end-user sterilization. | |
| Mechanical Performance (Strength/Fatigue) | The device is mechanically robust enough for its intended use. |
| Performance: Static compression and compression fatigue testing performed according to ISO 14801 of worst-case constructs (abutments, zirconia superstructures, abutment screws, compatible implants). The fatigue limit data demonstrated sufficient strength. Differences in superstructure design parameters (wall thickness, gingival height) were mitigated by mechanical testing. | |
| Manufacturing Process | The manufacturing process is consistent and yields safe devices. |
| Performance: Titanium alloy components manufactured from identical materials in identical facilities using identical processes as previously cleared products (K162021). Anodization process is also identical. | |
| Compatible Implant Interface | The device properly interfaces with specified implants. |
| Performance: Established compatibility with Thommen SPI® CONTACT dental implant fixtures (cleared in K034014 and K072933) via business agreement and identical interface connections/platforms. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document explicitly states "No clinical data were included in this submission." The "studies" were non-clinical (bench) tests. While the ISO 14801 standard specifies the number of samples for fatigue and static testing (typically 5-10 for static, 10-12 for fatigue), the exact sample sizes used for each specific test (e.g., number of abutments tested at different loads) are not detailed in this summary. It only says "worst-case constructs" were tested.
- Data Provenance: The data is non-clinical (bench testing) performed by the manufacturer or a contracted lab. The manufacturer is Talladium España, SL, located in Lleida, Spain. This indicates the testing was likely done in Spain or a European lab adhering to ISO standards. The data is retrospective in the sense that the tests were completed before the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. For a 510(k) submission based on non-clinical data, there are no "experts" establishing a clinical "ground truth" through consensus on patient cases. The "ground truth" for non-clinical testing is compliance with established engineering and biocompatibility standards (e.g., ISO 14801, ISO 10993). The "experts" here would be the engineers and scientists who designed and conducted the tests and analyzed the results according to these international standards. Their qualifications are inherent in their ability to perform such testing and demonstrate compliance with these standards.
4. Adjudication method for the test set
Not applicable. There's no clinical test set requiring adjudication. The non-clinical tests (biocompatibility, sterilization, mechanical) are evaluated against predefined acceptance criteria established by the relevant ISO standards.
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 device is a dental implant abutment, not an AI-powered diagnostic imaging tool. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
The "ground truth" for this 510(k) submission is compliance with established international engineering standards (e.g., ISO 14801 for mechanical performance, ISO 10993 for biocompatibility, ISO 17665-1 and ISO 11737-2 for sterilization) and the demonstration of substantial equivalence to predicate devices. This is achieved through:
- Bench Test Results: Quantitative data from static compression and compression fatigue tests.
- Material Specifications: Conformance to ASTM and ISO material standards.
- Biocompatibility Test Reports: Results showing no adverse biological reactions.
- Sterilization Validation Data: Proof of effective sterilization.
- Direct Comparison: Tables and textual analysis comparing the subject device's features and performance to those of legally marketed predicate devices.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for a physical device.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)