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The indications for use for Livento® press, Soprano® 10 and Soprano® are:

-Veneers

-Inlays and onlays

-Partial crowns

-Anterior and posterior tooth crowns

-Hybrid abutment crown

• -3-pontic bridge in anterior tooth region
  -3-pontic bridge in the premolar region up to max. 2nd premolar as a permanent abutment

The Livento/Soprano dental ceramic system comprise pressable ingots and compatible layering ceramic powders used in dental laboratories by the dental technician to create all ceramic restorations.

Livento® press is a pressable lithium disilicate glass-ceramic supplied in ingots of 3 grams. The material is supplied in different levels of translucency (MT, LT, ET, HQ, Opal and Bleach) each in different dental shades of Vita A, B, C and D.

Soprano® 10 is a layering fluorapatite glass-ceramic supplied as powder suitable for veneering substructures made from Livento® press lithium disilicate glass-ceramic and zirconium oxide. It has a range of different translucency levels (Frame Modifier, Opaque Dentine, Incisal/Enamel, Transparent, Clear) and is available in the Vita classic colors A, B, C and D as well as Bleach shades and Modifiers.

Soprano® shades, stains and glaze are glass ceramic dental porcelain material. They are intended to finish dental restorations and are offered in a variety of shades.

All Livento/Soprano dental ceramics meet the requirements of ISO 6872:2015.

The provided text describes a 510(k) premarket notification for a dental ceramic system (Livento® press, Soprano® 10, and Soprano®). The notification aims to demonstrate substantial equivalence to a predicate device, the DCceram System (K141400). The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the performance data presented to show compliance with relevant standards and justify substantial equivalence.

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

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

The document states that the Livento/Soprano dental ceramic system meets the requirements of ISO 6872:2015. This standard sets the acceptance criteria for dental ceramic materials. While specific numerical acceptance criteria from ISO 6872:2015 are not explicitly listed in the document, the tested parameters and the general statement of compliance serve as the reported performance against those criteria.

The document explicitly states: "The results show product compliance to the requirements of ISO 6872:2015."

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 mentions testing was done on "a representative sample of the products." However, it does not specify the exact sample size used for the performance testing.

Regarding data provenance:

• Country of Origin: Not explicitly stated, but the submitter (Cendres+Metaux SA) is located in Biel/Bienne, Switzerland. The testing would logically be conducted by or for a company based in Switzerland, or a contract lab.
• Retrospective or Prospective: This is a performance testing study, not a clinical study on patients. It's a laboratory study to characterize the material, so these terms (retrospective/prospective clinical data) do not directly apply. It's a prospective laboratory evaluation of material properties.

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 type of information (experts establishing ground truth) is typically relevant for studies involving human interpretation (e.g., medical imaging AI). For this submission, which focuses on the material properties of dental ceramics tested against a recognized international standard (ISO 6872:2015), the "ground truth" is defined by the physical and chemical properties of the material as measured by standardized laboratory methods, not by expert consensus. Therefore, this question is not applicable in the context of this device and submission.

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

As this is a laboratory performance study of material properties, not a study involving human readers or interpretations needing adjudication, the concept of an adjudication method is not applicable. The "ground truth" is established by the measurements themselves, evaluated against the specified criteria of ISO 6872:2015.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for medical image analysis devices, particularly those involving Artificial Intelligence (AI) to assist human readers. The device in question is a dental ceramic material used by dental technicians to create restorations, not a diagnostic imaging device or an AI application. Therefore, this question is not applicable.

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

No, a standalone performance study (in the context of AI algorithms) was not done. As stated, this is a material property evaluation, not an AI or software device. Therefore, this question is not applicable.

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

The "ground truth" for this device is the physical and chemical properties of the dental ceramic materials, as measured and characterized by standardized laboratory testing methods in accordance with ISO 6872:2015. This is a material science "ground truth."

8. The sample size for the training set

This question is typically relevant for AI/machine learning models where data is used to train an algorithm. Since this is a submission for a physical dental material with performance verified through adherence to an international standard, there is no "training set" in the sense of machine learning. The testing performed is for verification and validation of the product's physical properties.

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

As there is no "training set" in the context of this device submission, this question is not applicable.

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• Definitive supported and veneered crowns and bridges with maximum two pontics. Can be veneered with bonded press crowns, with composites or prefabricated acrylic teeth and veneers.
• Definitive supported, veneered single crowns and bridges with maximum one pontic on natural teeth.
• Removable restoration such as secondary structures on bars and telescopic crowns, transversal connectors, occlusal splints and denture bases.

Pekkton® Ivory is a semi-crystalline thermoplastic supplied in milling blanks and press blanks. By application of CAD/CAM milling or pressing technology according to the instructions for use, it can be used by the dental technician to manufacture permanent crowns, bridges and denture frameworks.

This document is a 510(k) premarket notification for a dental material called Pekkton® Ivory. It does not describe an AI/ML powered device, but rather a physical dental product. Therefore, the information requested about acceptance criteria and study proving the device meets the criteria, particularly regarding AI/ML specifics like MRMC studies, training/test sets, and expert adjudication, is not applicable to this document.

The document discusses the substantial equivalence of Pekkton® Ivory to a predicate device (BioHPP-breCAM.BioHPP) and a reference device (Pekkton® Ivory K123638). The "studies" mentioned are primarily non-clinical tests to assess biological, chemical, and physical properties of the material.

Here's an analysis of what is provided, framed as closely as possible to your request, but acknowledging the difference in device type:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a comparative table of technological characteristics between the predicate device (BioHPP-breCAM.BioHPP) and Pekkton® Ivory, along with relevant standards. These values serve as the "performance" data, and the comparison to the predicate and relevant ISO standards imply the "acceptance criteria."

Acceptance Criteria Statement: The document explicitly states: "Testing has shown that Pekkton® Ivory is equivalent in performance characteristics to the predicate device BioHPP. The acceptance criteria were met."

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

• Sample Size: The document does not specify exact sample sizes for each physical/chemical test (e.g., how many specimens were tested for flexural strength). It refers to "non-clinical test data."
• Data Provenance: The tests were conducted according to international standards (ISO, USP, ASTM). The country of origin of the data is implied to be Switzerland, where CENDRES+METAUX SA is based. The data is "retrospective" in the sense that the testing was completed prior to the 510(k) submission.

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 "ground truth" for a physical dental material is established through objective, standardized physical and chemical tests, not through expert consensus on interpretations like medical images.

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

• Not applicable. Adjudication methods are relevant for subjective assessments, typically in image interpretation or clinical outcomes, not for objective material property testing.

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 a physical dental material, not an AI-powered diagnostic device.

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

• Not applicable. This is a physical device.

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

• The "ground truth" for this device is based on objective, quantitative measurements of physical and chemical properties (e.g., melting temperature, bond strength, flexural strength, water absorption/solubility) derived from adherence to established international standards (ISO, ASTM, USP).
• For biological risks, the "ground truth" or assessment of safety is based on biocompatibility testing against recognized standards (ISO 10993 series and ISO 7405).

8. The sample size for the training set:

• Not applicable. There is no concept of a "training set" for physical material properties in this context, as there is no machine learning model involved. The manufacturing process and material formulation are "trained" through R&D and quality control, but not in the AI/ML sense.

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

• Not applicable. See point 8. The "ground truth" for the material's properties is established through the test methods and standards mentioned in point 7.

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The SFI-Anchor® D20 is intended for the fixation of (dental) prostheses to corresponding dental implants. The compatible implant systems are specified in Table 1 below. The SFI-Anchor® CD20 is intended as an additional retaining element on CAD / CAM milled dental bars.

The SFI-Anchor® D20 is an endosseous dental implant abutment for the fixation of (dental) prostheses to the following ITI Dental Implant System® / Straumann® Dental Implant Systems: Standard Ø 4.1 mm Regular Neck (RN) / Standard Ø 4.8 mm Regular Neck (RN) / Standard Plus Ø 4.1 mm Regular Neck (RN) / Standard Plus Ø 4.8 mm Regular Neck (RN) / Tapered Effect Ø 4.1 mm Regular Neck (RN) / Bone Level Ø 4.1 mm, Regular CrossFit® (RC) / Bone Level Ø 4.8 mm, Regular CrossFit® (RC). The SFI-Anchor® CD 20 is intended as an additional retaining element on dental bars. The SFI-Anchor® D20 are straight abutments with gingival heights ranging from 1mm to 5 mm. The SFI-Anchor® CD 20 is a straight bar attachment. The SFI-Anchor® Housing and the SFI-Anchor® Retention Inserts can correct for up to 10° of divergence (20° of divergence between two implants). The SFI-Anchor® is offered in a diameter 4.8 mm. The SFI-Anchor® D20 is connected to the corresponding implants via a mating screw thread and interface geometry. The SFI-Anchor® CD20 is directly screwed on a dental bar construct. The SFI-Anchor® Housing is cemented in the dental prostheses. The SFI-Anchor® Housing, along with an SFI-Anchor® Retention Insert, allow connection of the prosthesis to the abutment / bar attachment by retention-grip. The abutments / bar attachment are machined from Titanium Alloy conforming to ASTM F-136. Other SFI-Anchor® key functional parts are made out of Elitor® (conforming to standard ISO 22674) and of Pekkton® conforming to standard ASTM D3418, ASTM D638 and ASTM D790.

The provided text describes a dental implant abutment, SFI-Anchor® D20 and SFI-Anchor® CD20, and its substantial equivalence to predicate devices. It does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of AI/ML performance.

Therefore, I cannot provide the requested information. The document focuses on the mechanical and material characteristics of the dental abutments, their compatibility with implant systems, and a comparison with existing predicate devices to establish substantial equivalence for regulatory approval. It is not an AI/ML device.

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The SFI-Bar® is intended to be used with the implant manufacturer's implant (Table 1) to provide support for fixation of overdentures.

The SFI-Bar® provides the connection between compatible dental implant systems for the fixation of removable overdentures. The SFI-Bar@ consists of an implant adapter (abutinent) and a stress-free bar for the fixation of removable overdentures. The implant adapter is screwed into the dental implant.

Here's a breakdown of the acceptance criteria and study information for the SFI-Bar® based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a separate "test set" and its sample size in the context of clinical data for the SFI-Bar®. The performance evaluation relies on non-clinical test data.

Data Provenance: The testing was conducted as part of a 510(k) submission, originating from Switzerland (Cendres + Métaux SA, Biel/Bienne, Switzerland). The data is retrospective in the sense that it's an evaluation against established performance metrics and comparison to predicate devices, rather than a prospective clinical trial.

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

This information is not provided as the ground truth for this device's performance evaluation was based on engineering and performance testing rather than expert-derived clinical ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation did not involve human interpretation or adjudication processes like those in clinical image analysis studies. The adjudication for performance was based on meeting technical specifications from engineering tests.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices, which is not the nature of the SFI-Bar®.

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

This concept is not applicable to the SFI-Bar®. The device is a physical dental abutment, not an algorithm. The performance evaluation was of the physical device's mechanical properties and function.

7. The Type of Ground Truth Used

The ground truth for evaluating the SFI-Bar®'s performance was based on:

• Engineering specifications and standards: Adherence to established mechanical properties (e.g., torque, application, functional requirements).
• Performance characteristics of predicate devices: The SFI-Bar® was compared for substantial equivalence to legally marketed predicate devices, meaning their established safe and effective performance served as a benchmark.

8. The Sample Size for the Training Set

This information is not applicable. The SFI-Bar® is a physical medical device, not an AI/ML algorithm that requires a "training set."

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

This information is not applicable as there is no "training set" for this device.

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Pekkton® ivory is intended to be used for long-term, temporary dental crowns and bridges frameworks.

Pekkton® ivory is a semi-crystalline thermoplastic supplied in blanks. Pressing the blank gives a framework, from which the dental technician manufactures the final veneered dental crown and / or temporary dental bridge.

This document describes the premarket notification for the Pekkton® ivory dental device. The information provided focuses on demonstrating substantial equivalence to predicate devices and verifying the biological safety and performance of the device.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a clear, summarized format. However, it lists several biological evaluation tests and states that the "acceptance criteria were met."

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

The document does not specify the exact sample sizes for each test in the test set. It mentions that the studies were performed "in compliance with international GLP regulations," which implies controlled laboratory settings. The data provenance is from Cendres+Métaux SA, Switzerland, and the testing was retrospective (meaning conducted specifically for the 510(k) submission, not as part of an ongoing clinical trial).

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

This information is not provided. The testing described is primarily laboratory-based (biocompatibility, chemical, physical) rather than relying on human expert interpretation for ground truth.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not applicable/provided. The tests are objective laboratory measurements, not reliant on expert adjudication of results.

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

This information is not applicable/provided. The device is a dental material (Pekkton® ivory) and not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable/provided. The device is a material, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the test set was established through standardized laboratory testing protocols and established scientific methods, as defined by international standards (e.g., ISO 10993 series, USP 34 ) for biocompatibility, and material science methodologies for chemical and physical properties. For example:

• Biocompatibility: The "ground truth" for cytotoxicity was the observable impact on L929 mouse fibroblasts. For chemical characterization, it was the absence of product-related peaks in GG/MS / ICP analyses.
• Physical/Mechanical Properties: The "ground truth" was based on quantitative measurements (e.g., bond strength, fracture load, fatigue) compared against benchmarks from predicate devices or established material data sheets.

8. The Sample Size for the Training Set

This information is not applicable/provided. The submission describes a device validation through physical and biological testing, not a machine learning model that requires a "training set."

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

This information is not applicable/provided as there is no training set for a machine learning model.

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The SFI-Bar® is intended to be used with the implant manufacturer's implant (TABLE a) to provide support for fixation of overentures.

The SFI-Bar® provides the connection between compatible dental implant systems for the fixation of removable overdentures. The SFI-Bar® consists of an implant adapter (abutment) and a stress-free bar for the fixation of removable overdentures. The implant adapter is screwed into the dental implant.

Here's an analysis of the provided text to extract information about acceptance criteria and the study proving compliance for the SFI-Bar® device:

The provided document describes the 510(k) premarket notification for the SFI-Bar® device, a dental implant abutment. It seeks to establish substantial equivalence to predicate devices, rather than proving performance against novel acceptance criteria in a comprehensive clinical study.

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that the SFI-Bar® is equivalent in performance characteristics to the predicate SFI-Bar® and that acceptance criteria were met. However, the document does not explicitly list specific numerical acceptance criteria for performance metrics. Instead, it relies on demonstrating equivalence to the predicate device.

The "Performance Data" section mentions:

• Validation of Sterilization for metallic components.
• Evaluation of the intended manual disinfection procedure with SFI-Bar® Retention inserts G.
• Application and functional testing based on literature research.

The key acceptance criterion seems to be: "The SFI-Bar® is equivalent in performance characteristics to the predicate SFI-Bar®."

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

The document explicitly states: "Non-clinical test data was used to support the substantially equivalence claim. Clinical testing was not necessary."

This indicates that a "test set" in the sense of a patient cohort or a large sample for a clinical trial was not used for this submission. The testing performed was non-clinical.

• Sample Size for Test Set: Not applicable in the context of clinical or large-scale performance testing. The "test samples" mentioned in the context of "analysis of platforms to identify worst-case test samples" would likely refer to physical samples or configurations chosen for non-clinical engineering tests (e.g., sterilization, disinfection). The specific number of these non-clinical worst-case samples is not provided.
• Data Provenance: The submission is from Cendres+Metaux SA, Biel/Bienne, Switzerland. The non-clinical testing was conducted by the manufacturer, but the location where the tests were performed is not specified. The data is retrospective in the sense that it's based on existing designs and literature, and performed prior to this submission for regulatory clearance.

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

Not applicable. As clinical testing was not performed and the submission relies on demonstrating substantial equivalence through non-clinical data and comparison to predicate devices, there was no "ground truth" to be established by experts in a clinical context for a test set. The validation and evaluation mentioned primarily concern manufacturing processes and materials.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring expert adjudication was used.

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, a physical medical device, not an AI or imaging diagnostic tool. Therefore, MRMC studies and AI assistance are irrelevant to this submission.

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 or software.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Given the nature of the device and the submission, the "ground truth" relied upon is primarily:

• Engineering and material standards (e.g., ASTM F 136 for Titanium alloy).
• Performance characteristics of legally marketed predicate devices (K073628, K083876, K102382) as established through their prior regulatory clearances.
• Scientific literature research supporting application and functional principles.
• Validation of manufacturing processes (sterilization, cleaning).

There isn't "ground truth" in the sense of clinical outcomes or expert consensus on diagnostic interpretations.

8. The Sample Size for the Training Set

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

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

Not applicable. As there is no training set, there is no ground truth establishment for it.

In summary: The submission for the SFI-Bar® focuses on demonstrating substantial equivalence to existing predicate devices, leveraging non-clinical testing, material standards, and literature review. It does not involve new clinical trials, expert consensus, or AI performance metrics.

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The SFI-Bar® is intended to be used with the implant manufacturer's . (Table 1) implant to provide support for fixation of overdentures.

The SFI-Bar® provides the connection between compatible dental implant systems for the fixation of removable overdentures. The SFI-Bar® consists of an implant adapter (abutment) and a stress-free bar for the fixation of removable overdentures. The implant adapter is screwed into the dental implant.

The provided text describes a 510(k) submission for the SFI-Bar® Abutment, a dental device. The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list specific numerical acceptance criteria for each test. Instead, it states that "The acceptance criteria were met" and that the "SFI-Bar® is equivalent in performance characteristics to the predicate SFI-Bar®." The performance characteristics evaluated are generally described.

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

• Sample Size: The document does not specify the exact sample sizes used for the torque tests, application testing, or functional testing. It only states that these tests were conducted.
• Data Provenance: The data is non-clinical test data. The country of origin of the data is not explicitly stated, but the applicant (Cendres+Métaux SA) is located in Switzerland. The testing was conducted to support a 510(k) submission to the FDA (USA). The study is retrospective in the sense that it relies on existing testing methodologies and comparisons to a previously cleared predicate device.

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

This information is not applicable (N/A) as the study described is a non-clinical, bench testing study comparing the performance of a new device to a predicate device. There is no "ground truth" derived from expert review of cases or outcomes in a clinical context. The "ground truth" for the testing would be established by validated test methods and engineering specifications.

4. Adjudication Method for the Test Set

This information is not applicable (N/A) for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or patient outcomes, not in bench testing of a dental implant abutment.

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

This information is not applicable (N/A). The device described, the SFI-Bar® Abutment, is a physical dental implant component, not an AI or imaging diagnostic device. Therefore, an MRMC study and AI assistance effect size are irrelevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable (N/A). As mentioned in point 5, this is a physical dental device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this type of non-clinical device testing is engineering specifications, validated test methods, and the performance characteristics of the legally marketed predicate device. The goal is to demonstrate that the candidate device performs "as well or better than" the predicate device under the same test conditions. There isn't an "expert consensus," "pathology," or "outcomes data" ground truth in the clinical sense for this specific evaluation. The "worst-case test samples" were identified through analysis of platforms, indicating an engineering-based approach to defining test parameters.

8. The Sample Size for the Training Set

This information is not applicable (N/A). There is no concept of a "training set" in the context of this non-clinical bench testing for a physical dental device. Training sets are relevant for machine learning algorithms or similar data-driven models.

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

This information is not applicable (N/A), as there is no training set for this type of device submission.

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The SFI-Bar® is intended to be used with the SPI Element Platform 4.0 mm implant (K070007) to provide support for fixation of overdentures.

The SFI Bar consists of the following variants:

SFI-Bar® 2 Implant: Lower jaw: Connecting 2 or 2x2 implants in the intraforaminal region Upper jaw: Connecting 2x2 implants in the anterior/premolar region

SFI-Bar® 4 Implant: Lower jaw: Connecting 4 implants in the intraforaminal region Upper jaw: Connecting 4 implants in the anterior/premolar region

Not Found

I'm sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a dental implant abutment (SFI-Bar®), which primarily focuses on its substantial equivalence to a predicate device. It does not include details about acceptance criteria, study methodologies, sample sizes, ground truth establishment, or expert qualifications for performance evaluation.

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