Search Results

The Dentsply Sirona Titanium Bases system is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations.

For AT EV 3.0 S, AT TX 3.0 S, BH 3.0 S, and SB L 3.3 L titanium bases, the indication is restricted to the replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible.

The system comprises three parts:

• Abutment Block material (CEREC Cercon 4D Abutment Block)
• Titanium Base (TiBase)
• CAD/CAM system

The TiBase is recommended for use with two-piece hybrid abutments and hybrid abutment crowns, used in conjunction with endosseous dental implants.

The proposed Dentsply Sirona Titanium Bases system are connected to Dentsply Sirona or third-party dental implants to facilitate the prosthetic dental restoration of edentulous areas of the oral anatomy. The proposed TiBase components are assembled (through extraoral cement bonding) with the patient specific CEREC Cercon 4D Abutment Block (K234018), to form the complete, two-piece CAD/CAM Titanium Base system abutments. The bottom half of the abutment is the TiBase component, which interfaces with the implant system-specific geometry, while the top half of the abutment is the abutment block material that is milled to form either an abutment crown or a meso-structure (the latter is subsequently finished with a crown). The TiBase component therefore serves as the "platform" on which the customized milled abutment crown or the meso-structure is bonded to, forming the complete CAD/CAM Titanium Base system abutment. The completed CAD/CAM Titanium Base system abutment is attached to the dental implant with an abutment screw.

The TiBase system is part of a workflow that includes CAD/CAM software cleared in predicate device, K193408, CAD/CAM system with CEREC Chairside Software, and reference device, K200191, CAD/CAM System with inLab Software, and the abutment crown and meso-structure material cleared in reference device, K234018.

The TiBase components are made of the same material as the predicate device (K193408) TiBases, which is titanium alloy Ti6Al4V, complying with ASTM F136-13. While the lower part connects to the implant system, the upper part consists of a tapered, cylindrical center post which is designed to receive the abutment crown or meso-structure to complete the finished CAD/CAM abutment.

The TiBase components come in small and large sizes depending on the diameter size of the connecting implant. A notch feature on the cylindrical part of the upper portion (i.e. rotational reference and lock) ensures that there is only one position to mount either a scanbody or the abutment crown/meso-structure.

The TiBase component center post includes a through-channel through which a corresponding abutment screw is inserted to allow retention of the finished abutment to the implant. The abutment screw, made of the same Titanium material, when assembled with the proposed TiBase component, is located in the internal geometry of the titanium base and does not seat in the finalized abutment crown/meso-structure.

The minimum/maximum design specification limits are as follows:

• Maximum angulation for the Zirconia top-half material: 20˚
• Minimum wall thickness of the Zirconia top-half material: 0.5 mm
• Gingival heights of the TiBase component: 1, 2, 3 mm
• TiBase component post height (i.e., length above the gingival height): ≥ 4 mm

This document is a 510(k) clearance letter for the Dentsply Sirona Titanium Bases system, which specifies its indications for use and compares it to predicate and reference devices to demonstrate substantial equivalence. It does not describe the specific acceptance criteria and detailed study results that prove the device meets those criteria in a format applicable to AI/ML software performance studies.

The document details the technical aspects of the dental implant components and their mechanical testing for safety and performance (e.g., fatigue testing), biocompatibility, reprocessing validation, and MR compatibility. However, it does not involve the types of performance metrics, test set characteristics, or ground truth establishment typically associated with AI/ML device evaluations.

Therefore, for aspects related to AI/ML device performance (like accuracy metrics, expert review, MRMC studies, standalone performance), the answer is "Not applicable" or "Not provided" as this is a traditional medical device clearance, not an AI/ML software clearance.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several non-clinical tests that the device was subjected to and that it "met acceptance criteria" or "showed similar results" to reference devices. However, the specific quantitative acceptance criteria (e.g., "fatigue strength must be > X N") and the exact reported quantitative performance values achieved by the Dentsply Sirona Titanium Bases system are not explicitly stated in this clearance letter. The letter generally refers to compliance with standards.

For example, for fatigue testing, it states: "The TiBases systems were subjected to fatigue testing per the following requirements and showed similar results when compared to the reference devices (K213961, K241485)" and refers to ISO 14801:2016 and FDA Special Controls Guidance. It does not provide the numerical results or the specific acceptance mechanical load values. The same applies to MR testing, reprocessing, and biocompatibility.

2. Sample size used for the test set and the data provenance

• Sample Size: Not explicitly stated in terms of the number of unique devices/tests in the provided text. The fatigue testing mentions "the proposed device performs as well as the reference devices (K213961, K241485)," implying a comparison and potentially new tests for the specific new TiBases. However, specific counts are not given.
• Data Provenance: The studies are non-clinical (laboratory tests) rather than human patient data. Therefore, "country of origin" and "retrospective/prospective" are not applicable in the context of patient data. The tests were performed to demonstrate compliance with international standards (ISO, ASTM) and FDA guidance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable (N/A). This is a mechanical/material device clearance, not an AI/ML software evaluation based on expert-labeled data. The "ground truth" for these tests refers to the objective results conforming to engineering and material science standards (e.g., a device either fractures at a certain load or it doesn't, a material is biocompatible or not).

4. Adjudication method for the test set

• Not Applicable (N/A). Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert labeling for AI/ML ground truth, which is not relevant here.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No. This is not an AI/ML software device that involves human interpretation of medical images.

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

• Not Applicable (N/A). This is a physical device, not an algorithm. The "software system verification" refers to confirming that the CAD/CAM software correctly integrates the design parameters for the physical components, not an AI algorithm's standalone diagnostic performance.

7. The type of ground truth used

• For mechanical (fatigue) testing: Compliance with ISO 14801:2016 and FDA guidance, meaning the physical behavior of the device under specified loads.
• For MR testing: Compliance with ASTM standards, meaning objective measurements of displacement, torque, and image artifacts.
• For software verification: Conformation that design parameters are correctly implemented in CAD/CAM software.
• For reprocessing and biocompatibility: Compliance with ISO standards and FDA guidance, meaning objective evaluations of sterility and biological response.

8. The sample size for the training set

• Not Applicable (N/A). There is no AI/ML model involved; therefore, no training set.

9. How the ground truth for the training set was established

• Not Applicable (N/A). There is no AI/ML model involved; therefore, no training set.

Ask a specific question about this device

The TIB Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. The TIB abutments consist of two major parts. Specifically, the titanium base and mesostructure components make up a two-piece abutment. The system integrates multiple components of the digital dentistry workflow: Scan files from desktop scanners, CAM software, ceramic material, milling machine and associated tooling and accessories.

The intended use for the TiB narrow abutments used with the Ø3.0 mm External hex and Ø3.0 mm Deep Conical implants is limited to replacement of maxillary lateral incisors and mandibular lateral and central incisors.

The Narrow TIB Abutment bases are standard premanufactured titanium allov abutments for supporting a dental restoration and mesostructure. The dental laboratory is to fabricate the mesostructure restoration by CAD/CAM technique out of zirconia. The TIB abutment base then serves as the interface between the endosseous implant and the Zirconia restoration. The TIB Abutment Base is designed to support the restoration on an endosseous implant in order to restore chewing function for the patient.

The DC Ø3.0mm Narrow TiB abutments are only to be placed straight in the patient. Occlusal loading forces are only to be applied through the central longitudinal axis of the implant body.

The mesostructured restoration is a CAD/CAM designed prosthesis milled out of Zirconia, which is designed to fit the abutment base in order to restore chewing for the patient. Each restoration is custom designed using 3Shape Abutment Designer Software in order to meet the requirements of each patient on a case-by-case basis. Limitations have been put in place in 3Shape Abutment Designer in order to prevent malfunctioning of the restoration.

The subject Narrow TIB Abutments are compatible with the Southern Implants' Deep Conical and External Hex implants and screws. The subject TIB abutment bases are manufactured from Titanium alloy conforming to ASTM F136 and are color coded by gold anodizing. The anodization process is the same as used for previously cleared anodized titanium alloy devices in K193084. The mesostructured restoration is to be manufactured from Zirconia - Sage Max NexxZr which has been previously cleared for use in K130991.

The digital workflow includes the following products (not subject devices to this submission):

• Ceramic material: Sage Max NexxZr Zirconia Restorative material (K130991)
• . Cement: Ivoclar Vivadent Multilink Hybrid Abutment Cement (K130436)
• Intra-oral scanner ●
• . Lab scanner: 3Shape E3 Desktop Scanner (3Shape A/S)
• Abutment design software: 3Shape Abutment Designer Software (K151455) ●
• Milling machine: Roland DXW51D ●

This is a summary of the provided text regarding the TIB Abutments.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a tabular format with corresponding reported performance for the subject device. Instead, it demonstrates substantial equivalence by comparing the technological characteristics of the subject device (TIB Abutments) with primary and reference predicate devices. The implicit acceptance criterion is that the subject device's performance, as demonstrated by the listed tests and comparisons, is equivalent to the predicate devices.

Here's a table comparing the subject device's characteristics to the primary predicate, which serves as the basis for demonstrating equivalence:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document primarily relies on non-clinical performance data for mechanical fatigue testing (ISO 14801).

• Sample size: The specific sample size for the dynamic fatigue testing is not provided in the summary. It states "Dynamic testing was performed on worst-case subject device constructs." This typically implies multiple samples were tested to statistical confidence.
• Data provenance: The document does not explicitly state the country of origin of the data for the performance tests, nor whether it was retrospective or prospective. Given that this is a 510(k) submission for a South African company, it is likely the testing was conducted at a certified lab, possibly in South Africa or internationally, to ISO standards. The type of testing (mechanical fatigue) is inherently prospective in its execution (i.e., new tests are run on new devices).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This device is a physical dental implant component, not a diagnostic AI system or image analysis tool. Therefore, the concept of "ground truth" established by experts in the context of diagnostic accuracy or clinical interpretation is not applicable here. The "ground truth" for this device's performance is established by engineering tests and material science standards, such as ISO 14801 for mechanical fatigue.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a diagnostic device involving human interpretation that would require an adjudication method.

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 a physical dental implant component, not a diagnostic or AI-assisted device. No MRMC study was conducted or is relevant.

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

Not applicable. This is not an algorithm or software-only device in the context of a diagnostic or interpretive tool. The "digital dentistry workflow" involves software (3Shape Abutment Designer Software) but it's for design and manufacturing, not standalone diagnostic performance. Software validation was referenced from K193084.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the TIB Abutments is based on:

• Compliance with material specifications (e.g., Titanium Grade 5 Alloy (ASTM F136), Zirconia - Sage Maxx NexxZr).
• Performance against international engineering standards (e.g., ISO 14801 for dynamic fatigue testing).
• Biocompatibility established through material equivalence to a predicate device with established biocompatibility.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set mentioned for an AI/machine learning model.

Ask a specific question about this device