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The BTI Interna Dental Implant System UnicCa® - Prosthetic Components are intended to function in the mandible or maxilla to support single and multiple-unit temporary or definitive restorations on the BTI Interna® Dental Implant System implants.

All digitally designed zirconia components for use with Square Aesthetic Abutments and Aesthetic Interfaces for Transepithelials are to be sent to a BTI validated milling center for manufacture.

The purpose of this submission is to obtain marketing clearance for the subject device abutments, Square Aesthetic Abutments and Aesthetic Interfaces for Transepithelials, as part of a two-piece abutment with a zirconia superstructure fabricated using CAD-CAM technology.

The subject Square Aesthetic abutments are stock manufactured abutments, to be attached directly to BTI dental implants with the Interna implant connection (Narrow, Universal Plus and Wide platforms), to hold single or multiple restorations. The Square Aesthetic abutments are compatible with BTI implants previously cleared in K211952, K202825, K173257, and K151391. The subject Square Aesthetic abutments are provided in a variety of gingival heights ranging from 0.5 mm, with a prosthetic platform diameter ranging from 4.0 mm to 5.9 mm, and a prosthetic post height of 3.5 mm. All versions include anti-rotation indexes to prevent crown or bridge rotation. Engaging and non-engaging designs are available for single and multiple restorations, respectively. The abutments are used with cemented and screw-retained restorations.

The design parameters for the CAD-CAM fabrication of the patient-specific superstructures for use with the Square Aesthetic Abutments are:

minimum wall thickness - 0.45 mm minimum post height for single-unit restoration - 4.2 mm maximum gingival height - 6.0 mm minimum gingival height - 0 mm in the zirconia superstructure maximum angle - 0°, straight only.

The subject Aesthetic Interfaces for Transepithelials are stock manufactured abutments, used to support single or multi-unit definitive prosthetic restorations over BTI Transepthelial Abutments (Unit and Multi-im, respectively). The compatible Transepithelial Abutments were previously cleared in K213106 and the Transepithelial Abutments are compatible with the BTI Interna connection implants (Narrow, Universal, Universal Plus and Wide platforms), previously cleared in K211952, K202825, K173257, and K151391. The previously cleared Transepithelial Abutments have a minimum gingival height of 1.0 mm and the Aesthetic Interfaces for Transepithelials have a minimum gingival height of 0.3 mm; when used together (as required) the minimum gingival height is 1.3 mm. The Aesthetic Interfaces for Transepithelials are provided in a range of prosthetic diameters from 3.5 mm, with a range of post heights from 3.5 mm. The Aesthetic Interfaces for Transepithelials are provided in two configurations, Straight and Expanded configurations have a larger prosthetic platform diameter than the Straight configurations with the same platform diameter. Overall, the prosthetic platform diameters range from 3.5 mm to 6.5 mm.

The design parameters for the CAD-CAM fabrication of the patient-specific superstructures for use with the Aesthetic Interfaces for Transepithelials vary for the minimum wall thickness and prostheight depending on the design of the Aesthetic Interface and the corresponding Transepithelial Abutments. The overall design parameters for the CAD-CAM fabrication of the patient-specific superstructures for use with the Aesthetic Interfaces for Transepithelials are:

minimum wall thickness - 0.4 mm minimum post height for single-unit restoration - 4 mm maximum gingival height - 6.0 mm minimum gingival height - 0 mm in the zirconia superstructure maximum angle - 0°, straight only.

All zirconia superstructures for use with the subject device will be made at a B.T.I. Biotechnology Institute, S.L. validated milling center under FDA quality system regulations, and the material will conform to ISO 13356. All superstructures will be bonded to the abutment using Multilink Hybrid Abutment Cement (Ivoclar AG, cleared in K130436).

All subject device components are manufactured from unalloyed titanium conforming to ASTM F67 and ISO 5832-2 and are provided with a Titanium Nitride (TiN) coating to enhance of the device. All subject device components are used with abutment and prosthetic screws previously cleared in K213106, and K053355.

The provided text is a 510(k) summary for the BTI Dental Implant System UnicCa® - Aesthetic Post Abutments. It primarily focuses on demonstrating substantial equivalence to predicate devices based on design, materials, manufacturing, and intended use, rather than presenting a performance study with acceptance criteria for an AI/ML powered device.

Therefore, the requested information regarding acceptance criteria, study details (sample sizes, data provenance, expert qualifications, adjudication, MRMC studies, standalone performance), and ground truth establishment for a device performance study cannot be extracted from this document, as it describes a dental implant abutment, not a device whose performance is measured through such clinical or AI-centric metrics.

The document states: "No clinical data were included in this submission." This explicitly indicates that the type of study typically associated with performance criteria, and the establishment of ground truth for AI/ML models, was not part of this 510(k) submission.

The "Performance Data" section solely discusses non-clinical data related to:

• MRI review for components.
• Moist heat sterilization for non-sterile devices.
• Biocompatibility testing (cytotoxicity) for the final abutment.

These are standard engineering and material science performance tests for medical devices, not an evaluation of a diagnostic or therapeutic AI/ML device's accuracy or effectiveness in a clinical context.

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The BTI Dental Implant System UnicCa® for oral implant surgery is to be used for the partial or total replacement of teeth in edentulate patients. Once attached to the bone, the implants act as an anchor for various fixed or removable prosthetic solutions that can be used to improve or restore a patient's mastication function.

In the case of 5.5 – 6.5mm long UnicCa® implants should be used in a two-stage surgical procedure. These implants are indicated for delayed loading. These implants are indicated only for straight abutments and to support permanently fixed restorations.

In the case of Tiny® 3.0 UnicCa® implants: These implants shall be used only to replace maxillary lateral incisors and mandibular lateral and central incisors. Immediate loading is recommended when there is good primary stability and an appropriate occlusal load.

The BTI Dental Implant System UnicCa® is a self-tapping, threaded, root form dental titanium implant provided with two types of connections; external (i.e., Externa®) and internal (i.e., Interna®), in a variety of platforms and range of diameters (3.0 - 6.0 mm) and lengths (5.5 - 18.0 mm). BTI Dental Implant System UnicCa® features an implant surface treatment that improves the hydrophilicity of the implant.

The purpose of this 510(k) is to allow B.T.I. to expand the product offering for the Wide and Universal Plus 5.5 mm and 6.0 mm diameter Interna® implants to extend implant length up to 15 mm.

This document is an FDA 510(k) summary for the BTI Dental Implant System UnicCa®, which is a dental implant system. The submission describes modifications to the existing device, specifically expanding the available dimensions (diameter and length) of certain implants. Importantly, this is a modification of an already cleared device (predicate K151391), and the document emphasizes substantial equivalence rather than presenting an entirely new device's performance data.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

Strict acceptance criteria and performance data for the modified device itself are not explicitly presented as a pass/fail table in the document. Instead, the document relies heavily on demonstrating substantial equivalence to a previously cleared predicate device (K151391) and other reference predicates. The "performance data" provided relates to general device safety and effectiveness based on established standards and previous clearances, rather than a novel statistically powered study for the dimensional changes.

However, based on the provided text, we can infer the following:

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

The document does not describe specific sample sizes for a new test set for the modified dimensions. The overarching theme is that the modifications (dimensional changes) do not alter the fundamental design, materials, or intended use. Therefore, the data presented relies on previous testing for the predicate device.

• The biocompatibility testing, bench testing (fatigue, corrosion, hydrophilicity), shelf-life validation, and sterilization validation all refer back to studies performed for the predicate device K151391. No new samples or data provenance are explicitly stated for these tests regarding the new extended sizes.
• Human Factors Study: A Human Factors study was performed, but the sample size is not specified. The data provenance is implied to be prospective, specifically assessing the handling of the proposed single-barrier packaging.

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

This is not applicable as the document describes a dental implant system, not an AI/diagnostic device that typically requires expert-established ground truth for performance evaluation. The "ground truth" here is compliance with established engineering standards and safety/performance requirements for medical devices.

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

Not applicable for this type of medical device submission. Adjudication methods are typically used in clinical trial settings or for performance evaluation of diagnostic/AI devices where agreement among experts on a finding is critical.

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 dental implant (hardware), not an AI-assisted diagnostic or imaging device.

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

Not applicable. This device is a physical dental implant.

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

The "ground truth" for this device's acceptance is primarily based on:

• Compliance with recognized international and national standards (e.g., ISO 10993 series for biocompatibility, EN ISO 14801 for fatigue, ISO 5832-2 and ASTM F67 for material, ANSI ST72, USP, USP for endotoxins).
• Demonstration of substantial equivalence to previously cleared predicate devices through direct comparison of technological characteristics, materials, and intended use.
• Previous performance data from the predicate device (K151391) being deemed applicable to the modified device due to the nature of the changes (dimensional expansion within a similar design).

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

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The BTI Dental Implant System UnicCa® for oral implant surgery is to be used for the partial or total replacement of teeth in edentulate patients. Once attached to the bone, the implants act as an anchor for various fixed or removable prosthetic solutions that can be used to improve or restore a patient's mastication function.

In the case of 5.5 – 6.5mm long UnicCa® implants should be used in a two-stage surgical procedure. These implants are indicated for delayed loading. These implants are indicated only for straight abutments and to support permanently fixed restorations .

In the case of Tiny® 3.0 UnicCa® implants: These implants shall be used only to replace maxillary lateral incisors and mandibular lateral and central incisors. Immediate loading is recommended when there is good primary stability and an appropriate occlusal load.

BTI Dental Implant System UnicCa® is a self-tapping, threaded, root form dental titanium implant. Comprises two types of connections: Externa® and Interna® with a range of diameters (3.0 - 6.0 mm) and lengths (5.5 - 18.0 mm) for various platforms, we refer to Table 5-1. BTI Dental Implant System UnicCa® features an implant surface treatment that improves the hydrophilicity of the implant.

The provided text describes the acceptance criteria and the study conducted for the BTI Dental Implant System UnicCa®. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in a quantitative table for the clinical study. However, the reported device performance is:

The study implicitly aims to demonstrate that these survival rates are comparable to or exceed commonly observed rates in the literature (90% to 98%).

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size (Test Set): 170 patients with 430 BTI UnicCa implants.
• Data Provenance: Retrospective observational study. The country of origin of the data is not specified in the document.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The study is described as an "observational retrospective study," which typically involves reviewing existing patient records or clinical outcomes, rather than having experts establish ground truth for a new test set. The criteria for "implant survival" are defined (stable prosthesis, no pain, infections, pathology, absence of radiopaque images around implant, no loss/fracture/significant bone loss/infection), implying a clinical assessment standard.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

There is no indication of a Multi Reader Multi Case (MRMC) comparative effectiveness study or any involvement of AI in this document. The device is a dental implant, not an AI-powered diagnostic tool.

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

This is not applicable as the device is a dental implant, not a software algorithm.

7. The Type of Ground Truth Used

The ground truth for the clinical study was based on clinical outcomes and observations following implant insertion. This includes criteria such as:

• Stable prosthesis without pain, infections, or any pathology
• Absence of radiopaque images around the implant
• No implant loss or fracture
• Bone loss not exceeding 2-3mm
• No infection

8. The Sample Size for the Training Set

There is no mention of a training set as this study is a clinical evaluation of a physical medical device, not an AI model.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no training set mentioned.

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