Search Results

Dynamic TiBase abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.

Compatible Implant Systems:

All digitally designed custom abutments for use with Dynamic TiBase abutments are to be sent to a Talladium Medical validated milling center for manufacture.

Dynamic TiBase abutments are two-piece abutments composed of a CAD-CAM fabricated zirconia superstructure and a prefabricated titanium base component where the final two-piece abutment (base and cemented superstructure) is the finished device used for the prosthetic restoration. All subject device bases are made of titanium alloy (Ti-6Al-4V) conforming to ISO 5832-3 and ASTM F136. The Dynamic TiBase abutments are provided in engaging and non-engaging designs for single-unit and multi-unit restorations, respectively.

For each of the compatible OEM implant lines, the prefabricated titanium base components are provided with a gingival height (in the titanium base) ranging from 0.3 mm to 4 mm, and a platform diameter ranging from 4.30 mm to 5.50 mm. Angulation and additional gingival height may be provided in the zirconia superstructure. All Dynamic TiBase prefabricated titanium base components have a post with a cut-out to accommodate a restoration with an angled channel for screw access when clinically necessary. The post height of the prefabricated titanium base component ranges from 3.8 mm to 5.40 mm, and from 2.3 mm to 3.8 mm (cut-out height). The cementable post height of the final patient-matched abutment design, measured above the total combined gingival collar, shall be no less than 4 mm.

All zirconia superstructures (copings) used to complete the final two-piece subject device Dynamic TiBase abutment will be made at a Talladium España, SL validated milling center under FDA quality system regulations, and the material will conform to ISO 13356.

The design parameters for the CAD-CAM zirconia superstructure for the Dynamic TiBase vary slightly among the compatible OEM implants. The design parameters for the CAD-CAM zirconia superstructure are summarized in the following table:

(1) for the compatible sizes shown in Table 1
(2) minimum gingival height in the titanium base, not the zirconia superstructure

The required cement for bonding the zirconia superstructure to the Dynamic TiBases to create the final two-piece abutment is Nova Resin Cement cleared in K213609.

Also, the subject of this submission are seven (7) abutment screws for use with the subject abutments.

This FDA 510(k) clearance letter pertains to a dental implant abutment — the Dynamic TiBase — not an AI-powered diagnostic device or software. Therefore, the information typically requested about acceptance criteria and study designs for validating AI/ML-based medical devices (such as sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) is not applicable to this document.

The "performance data" section in this 510(k) summary refers to traditional engineering and biocompatibility testing for a physical medical device, not performance metrics for an algorithm.

Here's how to interpret the provided document in the context of "acceptance criteria" and "proof":

Acceptance Criteria and Reported Device Performance (as inferred for a physical device):

For a physical device like the Dynamic TiBase, the "acceptance criteria" are generally met through demonstrating substantial equivalence to a previously cleared predicate device. This involves validating material properties, manufacturing processes, functional performance (e.g., mechanical strength, compatibility), and biocompatibility.

The "study that proves the device meets the acceptance criteria" refers to the non-clinical testing performed to demonstrate substantial equivalence.

Regarding the specific questions about an AI/ML context:

1. A table of acceptance criteria and the reported device performance: Provided above, adapted for a physical medical device.
2. Sample size used for the test set and the data provenance: Not applicable. The "test set" for this physical device refers to the number of physical abutment samples or material samples subjected to mechanical, biocompatibility, and MRI testing. The document does not specify exact sample numbers for these engineering tests, only the standards used (e.g., ISO 14801 typically specifies minimum sample sizes). Data provenance is "non-clinical data" generated from laboratory testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a dental abutment's performance is established by engineering standards, material specifications, and physical testing, not by expert human interpretation of images or clinical outcomes in the same way as an AI diagnostic.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is a concept used in evaluating human reader performance in AI studies.
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 is for AI-assisted diagnostic devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This refers to an AI algorithm's performance.
7. The type of ground truth used: For a physical device, "ground truth" is defined by adherence to established engineering standards (e.g., ISO 14801 for mechanical strength), material properties, and biocompatibility standards. "Reverse engineering dimensional analysis" served as a form of "ground truth" for compatibility. No pathology or outcomes data was used for this premarket notification.
8. The sample size for the training set: Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) clearance is for a physical medical device (dental abutment), and the "performance data" section details the engineering and material testing conducted to demonstrate its safety and effectiveness, primarily through substantial equivalence to previously cleared devices. It does not involve AI/ML validation methodologies.

Ask a specific question about this device

ETIII Bio-SA Fixture System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including ; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The ETIII Bio-SA Fixture System is for single and two stage surgical procedures. It is intended for delayed loading.

ETIII Bio-SA Fixture has features of single threads, internal hex connection, taper body, and Bio-SA surface treatment. ETIII Bio-SA Fixture System is permanent dental implant made with Pure titanium Grade 4 (ASTMF67-06). The proposed device is sandblasted, acid etched, coated with calcium phosphate by immersing and then finally coated with hydrophilic materials (glucose and NaCl with saline concentrations).

The provided text is a 510(k) summary for a dental implant system (ETIII Bio-SA Fixture System) and does not contain information about an AI/ML-driven medical device. Therefore, it does not describe acceptance criteria, a study proving an AI device meets those criteria, or other details typically associated with the evaluation of AI/ML performance.

The document discusses:

• Device Description: An endosseous dental implant system made of pure titanium, with specific design features and surface treatment.
• Intended Use: For partially or fully edentulous mandibles and maxillae to support various dental restorations.
• Predicate Devices: Comparison with existing dental implant systems, highlighting the key difference of an added hydrophilic coating for improved wettability.
• Non-Clinical Testing:
  • Wettability and blood affinity observations.
  • Surface analysis (EDS, FE-SEM, ICP-AES).
  • Biocompatibility tests (cytotoxicity, sensitization, irritation, systemic toxicity, chromosome aberration, implantation, pyrogenicity) conducted according to ISO and FDA guidelines.
  • Animal study (Beagle dogs): Measured removal torque, bone loss, and bone-to-implant contact.
• Clinical Testing: A study with 45 subjects and 66 implants, evaluating primary stability, bone resorption, complications, and other factors, reporting a 100% success rate after 16.3 months average follow-up.
• Shelf-life validation and sterilization.

Summary of missing information relevant to AI/ML device evaluation:

Since this document pertains to a physical dental implant device and not an AI/ML-driven device, it does not contain any of the requested information regarding AI/ML performance criteria or studies.

Therefore, I cannot populate the table or answer the specific questions about AI/ML device acceptance criteria, study details, ground truth establishment, or human-in-the-loop performance.

Ask a specific question about this device