Search Results

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.

INTERNA 3.0 UnicCa® implants with a diameter of 3.3 mm are only intended 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.

INTERNA 3.0 UnicCa® implants with a diameter of 3.0 mm are only intended for replacement of maxillary lateral incisors and mandibular incisors, and are only intended for delayed loading.

INTERNA 3.0 UnicCa® implants with a diameter of 2.5 mm are only indicated for missing mandibular central and lateral incisors, and are only intended for delayed loading.

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

The purpose of this submission is to add components to the B.T.I. Biotechnology Institute, S.L. product line of endosseous dental implants, abutments, and prosthetic components. Specifically this submission seeks marketing clearance for dental implants with body diameters of 2.5 mm, 3.0 mm, various compatible conventional abutments, and two-piece abutments to be used with a zirconia superstructure fabricated using CAD-CAM technology.

The subject device Interna 3.0 implants have an internal hexolobular connection and a platform diameter of 3.0 mm. The implants are provided in body diameters of 2.5 mm, 3.0 mm. Each body diameter is provided in overall lengths of 8.5 mm, 10 mm, 11.5 mm. The subject implants are manufactured from unalloyed titanium (conforming to ASTM F67 and ISO 5832-2), and the endosseous surface has the UniCa" surface treatment that improves the hydrophilicity of the implant.

The subject device abutments are provided in various designs including Healing Abutments. Healing Screws, Temporary Titanium Abutments, Definitive Titanium Abutments, Square Abutments (Ti-Bases), Transeptihelial Abutments (Single-unit and Multi-unit, with corresponding screws), and Aesthetic Interfaces for Transepthelial Abutments. The Temporary Titanium Abutments and Definitive Titanium Abutments are provided straight (00) only and are not to be customized to create an angled abutment or to correct for angulation.

The subject Square Abutments are two-piece abutments consisting of titanium bases combined with ceramic superstructures, to be attached directly to the Interna 3.0 implants to support single-unit or multi-unit restorations. The Square Abutments are provided in gingival heights ranging from 0.5 mm to 3 mm, with a titanium base platform diameter ranging from 3.76 mm. The titanium base post height (length above the gingival height) either is 3.5 mm, or in versions with an angled screw access channel, 6.5 mm with a cut-down post height of 2.1 mm, 3 mm, or 3.5 mm. The post of all titanium base versions includes an anti-rotation design to prevent rotation of the superstructure or hybrid crown. The abutments are used with cemented and screw-retained restorations. The fabrication of the top-half of the abutment by conventional workflow was cleared in K211952, and a workflow using CAD-CAM technology to design and fabricate a superstructure or hybrid crown-abutment was cleared in K231827. The ceramic material to be used will be zirconia conforming to ISO 13356. All fabrication of the patient specific superstructures for use with the Square Abutments will be done at a BTI validated milling center. All superstructures will be bonded to the abutment using Multilink Hybrid Abutment Cement (Ivoclar Vivadent AG), cleared in K130436.

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

minimum wall thickness – 0.4 mm

minimum post height for single-unit restoration (post height is the length above the gingival height) – 4.0 mm maximum gingival height - 6 mm

minimum gingival height - 0.0 mm in the superstructure

(all Square Abutments have a minimum gingival height of 0.5 mm)

maximum angle - 0°, straight only.

Transepithelial Abutments are for supporting single-unit or multi-unit, temporary or definitive, restorations on the Interna 3.0 implants. Transepthelial Abutments are provided to fit implants with a body diameter of 2.5 mm, and to fit body diameters of either 3.0 mm. Transepithelial Abutments are provided in a variety of gingival heights ranging from 0.5 mm. Transepithelial Abutments are used with previously cleared BTI retention screws, temporary cylinders, aesthetic interfaces, and the subject device Interfaces for Transepithelial Abutments.

The subject Aesthetic Interfaces for Transepithelial Abutments are two-piece abutments on titanium bases combined with ceramic superstructures, used to support single or multi-unit definitive prosthetic restorations. Aesthetic Interfaces for Transepithelial Abutments are provided in gingival heights of 0.5 mm to 1.05 mm, titanium base diameters ranging from 3.5 mm, and titanium base post heights (length above the gingival height) ranging from 5.45 mm to 6.5 mm. Aesthetic Interfaces for Transepithelials are provided in two configurations, Straight and Expanded configurations have a larger titanium base platform diameter than the Straight configurations with the same platform diameter. The titanium base platform diameters range from 3.5 mm to 6.5 mm and all designs include anti-rotation indexes to prevent rotation of the superstructure or hybrid crown. The fabrication of the top-half of the abutment by conventional workflow was cleared in K211952 and a workflow using CAD-CAM technology to design and fabricate a superstructure or hybrid crown-abutment was cleared in K231827. The ceramic material to be used will be zirconia conforming to ISO 13356. All fabrication of the patient specific superstructures will be done at BTI validated milling center. All superstructures will be bonded to the abutment using Multilink Hybrid Abutment Cement (Ivoclar Vivadent AG), cleared in K130436.

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

minimum wall thickness - 0.4 mm

minimum post height for single-unit restoration (post height is the length above the gingival height) – 4 mm

maximum gingival height - 6 mm

minimum gingival height - 0.0 mm in the superstructure

(all Aesthetic Interfaces have a minimum gingival height of 0.5 mm)

maximum angle - 0°, straight only.

All subject device abutments are manufactured from unalloyed titanium conforming to ASTM F67 and ISO 5832-2, and zirconia confirming to ISO 13356. Selected abutments are provided with a Titanium Nitride (TiN) coating to enhance the aesthetic appearance of the device. Subject device abutments used with screws previously cleared in K211952 and K053355. The screws that are part of the Transepithelial Abutment assemblies are manufactured from Ti-6Al-4V alloy conforming to ASTM F136 and ISO 5832-3. The screws have a diamond-like carbon (DLC) coating that is identical to the DLC coating on screws cleared in K211952.

Subject device components provided sterile by gamma irradiation include the Interna 3.0 Implants, Healing Abutments, Healing Screws, and Transepithelial Abutments. Components provided non-sterile for end-user moist heat sterilization include the Temporary Titanium Abutments, Definitive Titanium Abutments, Square Abutments, Aesthetic Interfaces for Transepithelial Abutments, and retention screws.

This document, K240262, is a 510(k) premarket notification for a dental implant system. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an Artificial Intelligence/Machine Learning (AI/ML) device. The non-clinical data submitted or referenced in this document are for a traditional dental implant system and include:

• Worst-case MRI review.
• Measurements of surface area comparisons with predicate implants.
• Moist heat sterilization validation.
• Gamma sterilization validation.
• Sterile barrier shelf life data.
• Biocompatibility data for device materials.

Therefore, I cannot extract the requested information in the format of acceptance criteria and a study proving the device meets the acceptance criteria for an AI/ML device from the provided text. The document explicitly states: "No clinical data were included in this submission." and the device is a dental implant system, not an AI/ML device used for diagnostic or screening purposes that would require such performance studies.

Ask a specific question about this device

The BTI Interna 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.

All digitally designed zirconia components for use with Aesthetic post abutments are to be sent to a BTI validated milling center for manufacture.

The purpose of this 510(k) is to expand the BTI product offering and include a variety of abutments compatible with the already cleared BTI Dental Implants. Subject device abutments include 15° Angled abutments, Transepithelial abutments, Temporary titanium abutments, Healing caps, Aesthetic post abutments and Screws. Aesthetic post abutments include Square abutments and Aesthetic interfaces for Transepithelials, as the bottom part of a two-piece abutment. A zirconia superstructure fabricated through CAD-CAM technology is the upper part of the two-piece abutment.

The subject 15º Angled Titanium abutments are designed to a BTI Interna Narrow implant, to hold single and multiple cement-retained restorations. The compatible BTI implants have been previously cleared in K211952. The abutments are offered with a 15º angulation and gingival heights of 3.0, 4.0, and 5.0 mm. They are manufactured in commercially pure titanium, with a TiN coating to enhance abutment aesthetic appearance.

The subject Temporary abutments are designed for single-unit screw-retained restorations on Transepithelial abutments are offered in prosthetic diameters of 3.5, 5.0 and 5.5 mm, with no angulation. They are manufactured from commercially pure titanium.

The subject Transepithelial abutments are designed for single-unit and multi-unit screw-retained restorations on previously cleared BTI implants. The compatible BTI implants have been previously cleared in K211952, K202825, K173257, and K151391. They are available in an engaging and a non-enqaging connection. They are offered in a prosthetic platform diameter of 3.5, 5.0 and 5.5 mm, and gingival heights ranging from 0.5 to 5.0 mm, with 0°, 17° and 30° angulation. They are manufactured from commercially pure titanium, with a TiN coating on abutment surface. The retention screw is provided with the abutment and is manufactured from titanium alloy with a DLC coating.

The subject Healing caps are designed to be connected to a Transepithelial abutment implant during the healing period, between Transepithelial placement and final dental restoration placement. These abutments are provided in prosthetic diameters of 3.5 and 5.0 mm. They are manufactured from commercially pure titanium and anodized.

The subject Aesthetic interfaces are two-piece abutments composed of a bottom half titanium component, and a patient-specific designed CAD-CAM zirconia superstructure as a top half component. The Aesthetic interfaces are to be attached to a Transepithelial abutment to hold single or multi-unit restorations. They are fabricated from commercially pure titanium, with a TiN coating to enhance abutment aesthetic appearance.

The design parameters for this top-half abutment fabrication are as follows:

• Minimum wall thickness: 0.4 mm -
• Minimum post height for single-unit restorations: 4.0 mm -
• Minimum gingival height: 0 mm in the zirconia superstructure -
• -Maximum gingival height: 6.0 mm
• -Maximum angulation: 0°

The subject Square abutments are two-piece abutments, composed of a bottom half titanium component, and a patient-specific designed CAD-CAM zirconia superstructure as a top half component. The Square abutments are to be attached to a BTI implant to hold single or multi-unit restorations. The compatible BTI implants have been previously cleared in K211952, K202825, K173257, and K151391. They are fabricated from commercially pure titanium, with a TiN coating to enhance abutment aesthetic appearance. The subject Square abutments are straight abutments (0%, and are provided in a variety of gingival heights ranging from 0.5 mm to 3.0 mm.

The design parameters for this top-half abutment fabrication are as follows:

• Minimum wall thickness: 0.4 mm -
• -Minimum post height for single-unit restorations: 4.0 mm
• Minimum qingival height: 0 mm in the zirconia superstructure -
• Maximum gingival height: 6.0 mm -

The zirconia superstructures for use with the subject Square abutments and Aesthetic Interfaces will be made at a BTI validated milling center and the material will conform to ISO 13356. The bonding cement recommended for the zirconia superstructure is Multilink Hybrid Abutment Cement (Ivoclar Vivadent AG), cleared in K130436.

The subject Screws are designed to attach Square abutments and Aesthetic Interfaces to the compatible BTI dental implant or Transepithelial abutment, respectively. The Screws are manufactured from titanium allov, with a DLC coating on screw thread. One subject Screw is also anodized for ease identification.

I am sorry, but the provided text does not contain the necessary information to describe the acceptance criteria and the study proving the device meets them, as it is a 510(k) summary for dental prosthetic components. This type of document focuses on demonstrating substantial equivalence to previously cleared devices rather than on performance studies with specific statistical acceptance criteria for a device involving AI or software.

The document discusses:

• Device Name: BTI Interna Prosthetic Components
• Regulatory Information: Class II device, product code NHA, regulation number 21 CFR 872.3630 (Endosseous Dental Implant Abutment).
• Indications for Use: To function in the mandible or maxilla to support single and multiple-unit temporary or definitive restorations on the BTI Interna® Dental Implant System. It also mentions that digitally designed zirconia components are to be sent to a BTI validated milling center for manufacture.
• Predicate Devices: Lists several predicate and reference devices, primarily other BTI Interna components and systems, and components from other manufacturers like AccelX Abutments and Medentika GmbH.
• Device Description: Detailed descriptions of various abutment types (15° Angled, Transepithelial, Temporary titanium, Healing caps, Aesthetic post abutments, and Screws), their materials (commercially pure titanium, zirconia), coatings (TiN, DLC), and design parameters (e.g., wall thickness, post height, gingival height, angulation).
• Performance Data (Non-clinical):
  • Moist heat sterilization validation.
  • Biocompatibility testing (ISO 10993-5 and ISO 10993-12).
  • Mechanical testing (ISO 14801).
  • Coating characterization.
  • Non-clinical worst-case MRI analysis.
  • Crucially, it explicitly states: "No clinical data were included in this submission."
• Technological Characteristics and Substantial Equivalence Discussion: A comparative analysis of the subject device with predicate and reference devices regarding indications for use, materials, surface treatment, restoration types, fixation methods, compatible implant platforms, dimensions (gingival height, angulation, prosthetic diameter), sterilization status, and packaging.

Why the requested information cannot be found in the provided text:

The request is for information typically found in the clinical study section of a submission for a device, especially those involving AI or software, where performance against a ground truth is evaluated. The provided document is a 510(k) summary for implant prosthetic components, which are mechanical devices, not AI/software. Therefore, concepts like "acceptance criteria" related to AI performance metrics (e.g., sensitivity, specificity), test set sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or training set details are not applicable and not present in this document.

The "Performance Data" section in this document refers to non-clinical bench testing (sterilization, biocompatibility, mechanical strength, material characterization, and MRI compatibility) to demonstrate the physical and material properties of the dental components, and it explicitly states that no clinical data was included.

To answer your request, a different type of FDA submission document (e.g., one for an AI/ML-driven diagnostic or screening tool) would be required.

Ask a specific question about this device

INNO SLA Submerged Narrow Implant System is intended for two-stage surgical procedures in the following situations and with the following clinical protocols:

• The intended use for the 3.3mm, 3.5mm diameter INNO Sub Narrow Implant is limited to the replacement of maxillary lateral incisors and mandibular incisors.

• Immediate placement in extraction situations with a partially or completely healed alveolar ridge.

• It is intended for delayed loading.

The INNO SLA Submerged Implant System offers the following components.

1 INNO SLA Submerged Narrow Fixture (Narrow) Ø 3.3 x 8.00, 10.00, 12.00, 14.00 mm Ø 3.5 x 8.00, 10.00, 12.00, 14.00 mm
2 Cover Screw (Narrow) Ø 2.84 x 5.0 mm Ø 3.23 x 6.0 mm Ø 3.62 x 7.0 mm
3 Healing Abutment (Narrow) Type 1 Ø3.5 x 6.7, 7.2, 9.2, 10.2, 11.2 mm
4 Healing Abutment (Narrow) Type 2 Ø 4.5 x 7, 9, 10, 11, 12, 14 mm
5 Cemented Abutment (Narrow) Ø 4.5 x 7.85, 8.85, 9.85, 10.85, 11.85, 12.85, 13.85, 14.85mm Ø 4.5 x 9.35, 10.35, 11.35, 12.35, 13.35 mm Ø 4.5 x 7.65, 8.65, 9.65, 10.65, 11.65, 13.65, 14.65 mm Ø 4.5 x 9.15, 10.15, 11.15, 12.15, 13.15 mm
6 Angulated Abutment (Narrow) Ø 4.5 x 11.85, 12.85, 13.85, 14.85 mm (15°, 25°)
7 Multi S Abutment Ø 4.5 x 5, 5.8, 6mm
8 Multi A Abutment Ø 4.5 x 6.42, 7.42, 8.42, 6.96, 7.96mm (15°,30°) – Hex type Ø 4.5 x 6.23, 7.22, 8.22, 6.76, 7.76mm (15,30°) – Non Hex type
9 Multi Hybrid Ti-Base Cylinder Ø 4.5 x 4.5mm
10 Abutment Screw (Narrow) Ø 2.25 x 10.2 mm Ø 1.95 x 8.7 mm
Ø 1.95 x 9.3 mm
12 Multi Cylinder Screw Ø 2.25 x 5 mm
13 Straight Abutment Ø 3.5 x 13.5, 14, 15, 16, 17 mm
14 Temporary Abutment Ø 4.5 x 10 mm
15 Multi Titanium Cylinder Ø 4.5 x 9 mm

The provided document is a 510(k) premarket notification for a medical device (INNO SLA Submerged Narrow Implant System). This type of document focuses on demonstrating substantial equivalence to legally marketed predicate devices, not on proving clinical effectiveness or meeting specific performance acceptance criteria through a dedicated study.

Therefore, the document does not contain any information regarding:

• Acceptance criteria in the traditional sense of a clinical or performance study with numerical targets for metrics like sensitivity, specificity, accuracy, etc.
• The study that proves the device meets acceptance criteria (as no such study with performance metrics is presented).
• Sample size used for the test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance.
• Ground truth type for a performance study.
• Sample size for the training set.
• How the ground truth for the training set was established.

Instead, the document focuses on demonstrating substantial equivalence through:

1. Performance Data (Non-Clinical):

The performance testing listed focuses on engineering and material characteristics, leveraging previous clearances and established standards.

• Gamma radiation sterilization and shelf-life: Leveraged from Cowellmedi Co., Ltd.'s previous clearance K132242.
• Steam sterilization of abutments: Leveraged from Cowellmedi Co., Ltd.'s previous clearance K201323.
• Five-year shelf life and packaging: Leveraged from Cowellmedi Co., Ltd's previous clearance K132242.
• SLA surface treatment: Leveraged from Cowellmedi Co., Ltd.'s previous clearance K132242.
• Fatigue test in accordance with ISO 14801: This is an engineering test to ensure the mechanical integrity of the implant system. The document states: "We have performed the fatigue test to make sure the differences do not raise and the test result of the test supported substantial equivalence." However, no specific numerical acceptance criteria or results are provided in the summary.
• Biocompatibility endpoints: Leveraged from Cowellmedi Co., Ltd.'s previous clearance K132242.
• Non-clinical worst-case MRI review: Performed using scientific rationale and published literature to evaluate displacement force and torque.

2. Substantial Equivalence Discussion and Comparison Chart:

This section directly compares the subject device (INNO SLA Submerged Narrow Implant System) with various predicate and reference devices, highlighting similarities in:

• Intended Use
• Material (Titanium Grade 4 or Ti-6Al-4V ELI)
• Principle of Operation
• Design
• Surface Treatment (SLA, TiN Coating)
• Sterility (Gamma Sterilization, Non-sterile with terminal sterilization via moist heat/autoclave, End User Sterilization)
• Shelf Life (5 years)

The document asserts that slight differences, such as in abutment size options or diameter ranges, do not affect substantial equivalence or raise concerns about safety or performance.

In summary, for a traditional clinical or AI/ML performance study as requested, all fields would be "Not Applicable" or "Not Provided" based on the content of this 510(k) summary. The "acceptance criteria" here are implicitly that the device performs equivalently to the listed predicates based on the non-clinical tests and functional comparisons detailed.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

The purpose of this 510(k) is to obtain marketing clearance for expanding the catalogue of abutments and prosthetic components for the Universal Plus and Wide platform of the BTI Interna® Dental Implant System. The premarket notification includes a set of different abutments and screws: UNIT transepithelial abutments, Aesthetic Interfaces, Square Aesthetic Abutments, Angled Titanium Abutments and MULTI-IM transepithelial abutment screws compatible with the cited previous platforms of the BTI Implant System Unicca® in its internal engaging connection version. The implant to abutment connection of all set of abutments range from 4.1mm to 5.5mm. All subject devices are provided sterile via Gamma Radiation. All abutment configurations are not to be used with compatible BTI Interna implant bodies placed at angle (no angular correction), with the exception of the subject Angled Titanium Abutments.

The subject device Transepithelial abutments are straight abutments designed for single (UNIT) and multiple (MULTI-IM) screw-retained restorations. These transepithelial abutments are provided in a range of gingival height from 1.0mm to 4.0mm. All designs have a prosthetic diameter of 5.5mm.

Aesthetic Interfaces are the compatible attachments used to support definitive restorations over transepithelial abutments. Two models are available: Square Aesthetic Interfaces used in single restorations and Aesthetic Interfaces for multiple restorations. Square Aesthetic Interfaces are characterized by an engaging connection to UNIT transepithelial abutments and by four anti rotation lobes placed in prosthetic parts. Aesthetic Interfaces has a conical design with a non-engaging connection to MULTI-IM transepithelial abutments. Prosthetic diameter of aesthetic interfaces can be 5.5mm or 6.5mm, and prosthetic height, 3.5mm or 4.2mm. Aesthetic Interfaces are attached to the transepithelial abutments with their specific retention screws, MULTI-IM transepithelial abutments screws.

The proposed device Square Aesthetic Abutments are straight abutments design for single and multiple restorations in screwed or cemented restorations via traditional casting techniques. The engaging /non-engaging implant abutment connection has a diameter of 4.1mm or 5.5mm, depending on the compatibility with the implant. Square Aesthetic abutments are available in a range of gingival heights from 0.5 to 3.5mm.

Angled Titanium Abutments are premanufactured abutments directly used into the implant in single and multiple cemented restorations. These devices compensate up to 15° misalignment of implants between implant axis and prosthesis axis. Angled Titanium abutments are available in two gingival heights (2 or 4mm) and are compatible with Wide Implant Platform.

All abutments and interfaces are made of unalloyed conforming to ASTM F67 and are coated with titanium nitride (TiN). MULTI-IM transepithelial screws are manufactured in titanium alloy in accordance with ASTM F136, and the surface of the screw thread is coated with tungsten carbide/carbon and chromium (WC/C).

I am sorry, but the provided text does not contain information about acceptance criteria and a study that proves a device meets those criteria. The document is a 510(k) summary for a dental implant system, detailing its substantial equivalence to predicate devices based on non-clinical testing and comparative analysis of technological characteristics. There is no mention of specific acceptance criteria for performance metrics that would typically be evaluated in a study, nor is there a description of a clinical or non-clinical study designed to prove the device meets such criteria.

Ask a specific question about this device