Search Results

Hard Splint is a 3D print light curable resin for the fabrication of orthodontic and dental appliances such as splints, mouthguards, nightguards, repositioners and retainers.

Thermo-adaptive Splint is a 3D print light curable resin for the fabrication of orthodontic and dental appliances such as splints, mouthguards, nightguards, repositioners and retainers.

Whip Mix Dental Resin is light cured resin that is provided in a plastic container, and it is a proprietary blend of ingredients that make a generative resin. When the system (which includes a scanner, design software, printer software, resin, 3D printer, and curing unit) are used in combination, the result is an additive manufactured orthodontic, thermo-flexible orthodontic, or dental appliances such as mouthguards, splint, nightguards, repositioners and retainers.

The provided text describes a 510(k) premarket notification for two light-curable resins, "Hard Splint" and "Thermo-Adaptive Splint," for fabricating dental appliances. It mainly focuses on the substantial equivalence to predicate devices based on technological characteristics and non-clinical tests. However, it does not contain information related to software performance, AI algorithms, human-in-the-loop studies, or the acceptance criteria for such systems.

Therefore, I cannot provide a table of acceptance criteria and reported device performance related to AI or software, nor can I answer questions about sample sizes for test sets, data provenance, expert-established ground truths, adjudication methods, MRMC studies, standalone algorithm performance, or training set details. This document pertains to the material properties and biocompatibility of the resins, not the performance of a diagnostic or analytical device with acceptance criteria involving sensitivity, specificity, or other performance metrics typically associated with AI.

Ask a specific question about this device

Whip Mix VeriSplint is a light-cured resin. It is a polymer used to create removable structures for therapeutic restorations i.e., bite guards/splints and occlusal night guards/splints using the Additive Manufacturing process. The resin in combination with a scanner, printer, and curing unit make up the system.

The VeriSplint ®OS system is a combination of a scanner, resin, 3D printer, and curing unit. The system components work together to manufacture a splint/bite guard. The additive manufactured appliance is part of a photo-cured product family that is a combination of methacrylate resins. In general, the products in this family are composed of a 3-component methacrylic system, polymerized via photo initiators in a 3D printer setting. The material is an alternative to traditional heat cured and auto polymerizing resins.

The provided text describes the Whip Mix VeriSplint device and its performance testing to demonstrate substantial equivalence to predicate devices, primarily for its physical and chemical properties as a dental material. It does not describe a study involving human-in-the-loop performance, expert ground truth establishment for a test set, or MRMC studies, as would be common for AI/ML-based medical devices.

Therefore, many of the requested elements for the acceptance criteria and study proving device performance (specifically those related to AI/ML and human reading studies) are not applicable to the information provided in this document.

Here's the information that can be extracted from the provided text, focusing on the material characteristics and the regulatory review process for VeriSplint:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are based on the requirements of ISO 20795-2:2013, Dentistry – Base Polymers – Part 2: Orthodontic base polymers, and comparison to predicate devices.

Ask a specific question about this device

Vericore ® Gradient Temporary discs is a device made from Polymethylmethacrlate. It is used to mill/fabricate temporary crown or bridge for use in the oral cavity for up to six (6) months while awaiting a permanent restoration. Restorations are designed virtually by a dental professional/technician then manufactured (milled) using CAD technology.

Vericore ® Gradient Temporary Discs is a device made from high quality PMMA (polymethylmethacrylate) that is >98%. It is intended for use in the oral cavity as a temporary restoration up to six (6) months while awaiting a permanent restoration. Two (2) pontics are allowed between two (2) abutment teeth. Restorations are designed by the dental technician using CAD technology and uses scans or models from the basis of the restoration to be milled. Vericore ® Gradient Temporary Discs are circular in form and available in a variety of thicknesses for different milling systems and are also available in Vita shades of A1, A2, A3, B1, B2, and Bleach. The device is fabricated in the standard dental laboratory environment.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

Device: Vericore® Gradient Temporary Disc (K152443)
Predicate Device (Primary for performance): Copra-Temp discs manufactured by White Peaks Dental Systems (K131664)

1. Table of Acceptance Criteria and Reported Device Performance

The document provides performance data primarily in comparison to a predicate device, and against ISO standards. The acceptance criteria are implicitly derived from the ISO standard requirements.

Summary of Device Performance against Acceptance Criteria:

• Flexural Strength: The device's reported flexural strength (82 MPa) meets the minimum requirement of 50 MPa per ISO 10477.
• Chemical Solubility & Water Sorption: The document states that "all tests passed the requirements" for these two characteristics according to ISO 10477. The specific numerical acceptance criteria from the ISO standard are not explicitly listed, but the reported values (-0.2 µg/mm³ for solubility and 22 µg/mm³ for water sorption) are provided in comparison to the predicate. The statement "all tests passed the requirements" implies these values were within acceptable limits.
• Biocompatibility: The device demonstrated no irritation effects on test subjects for the oral mucosa, indicating it met the biocompatibility requirements related to its specific shading ingredients.

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

• Sample Size for Test Set: Not specified in the provided document. The tests conducted (Flexural Strength, Water Sorption, Chemical Solubility, Biocompatibility focusing on irritation effects) would have involved specific numbers of samples, but these are not detailed.
• Data Provenance: Not specified in terms of country of origin or retrospective/prospective nature. The testing was conducted by Whip Mix Corporation ("Whip Mix performed biocompatibility test...") for the specific shading ingredients, or referenced predicate data based on similar testing ("same tests as performed on the predicate K131664" and "White Peaks performed biocompatibility tests").

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

• This information is not applicable to this type of device and study. The testing described (mechanical properties and biocompatibility) relies on objective measurement and laboratory analysis, not expert consensus or interpretation of subjective data like images. There is no "ground truth" established by experts in the context of diagnostic accuracy for this device.

4. Adjudication Method for the Test Set

• This information is not applicable as there is no "adjudication" in the context of mechanical properties or biocompatibility testing for this device. The results are based on objective measurements against defined standards.

5. If a Multi Reador Multi Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human readers interpreting cases (e.g., radiology AI). The Vericore® Gradient Temporary Disc is a dental material, not a diagnostic imaging device.

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

• No, a standalone algorithm-only performance study was not done. This device is a physical material, not an algorithm or AI system.

7. The Type of Ground Truth Used

• For Flexural Strength, Chemical Solubility, and Water Sorption: The "ground truth" (or reference standard) is established by physical measurements according to the protocols defined in ISO 10477.
• For Biocompatibility: The "ground truth" is established by biological response assessments (e.g., observing for irritation effects) conducted according to relevant parts of the ISO 10993 series (specifically mentioned: ISO:10993-3, ISO:10993-5, and ISO:10993-10 for the predicate, and performed for oral mucosa irritation for the new device).

8. The Sample Size for the Training Set

• This concept is not applicable. This device is a physical dental material, not a machine learning model that requires a "training set."

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

• This concept is not applicable as there is no training set for this type of device.

Ask a specific question about this device

Vericore zirconia blanks are made from pre-sintered zirconium dioxide intended to be used with many CAD/CAM or manual milling machines. Vericore zirconia blanks are biocompatible and designed to fabricate;

• Zirconia Substructures .
• -Restorations (Including inlays, onlays, and veneers)
• . Crown Framework in the Anterior and Posterior regions
• . Bridge Framework in the Anterior and Posterior regions

Vericore Zirconia Blanks is a device made from pre-sintered zirconia powder. It is available in various shades, shapes, and sizes to accommodate the customers CAD/CAM or manual milling equipment/strategies and is not machine specific. Vericore Zirconia Blanks are made from a biocompatible zirconia powder. It is intended to be used by professionals for the fabrication of dental restorations.

The provided text is a FDA 510(k) premarket notification for a dental device, "Vericore Zirconia Blanks". This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of a device's performance against specific acceptance criteria in a clinical setting. Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment for a clinical study is not available in the provided text.

However, I can extract information related to the bench testing conducted.

Here's a breakdown of the available information:

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

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

• Sample Size: Not specified for the bench tests.
• Data Provenance: Not specified, but generally, bench testing data for medical devices would originate from the manufacturer's testing facilities (likely in the USA, given the applicant's address). The tests are prospective in nature as they are conducted for this specific submission.

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)

• Not applicable. Bench testing does not typically involve human experts for establishing ground truth as it measures material properties based on established standards.

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

• Not applicable. Bench testing does not involve adjudication.

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 document 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

• No, a standalone performance study was not done. This document is for a physical dental material, not an algorithm.

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

• For the bench tests (Flexural Strength, Chemical Solubility, Density), the "ground truth" is based on established international standards (ISO 6872) for material properties.

8. The sample size for the training set

• Not applicable. This is a physical dental material, not a machine learning algorithm, so there is no "training set."

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

• Not applicable. There is no training set for a physical dental material.

In summary, the provided document details the regulatory submission for a dental material (Vericore Zirconia Blanks). The "study" described refers to bench testing to ensure the material meets specified physical and chemical properties according to international standards (ISO 6872). It does not involve a clinical study with human subjects, expert readers, or AI performance metrics.

Ask a specific question about this device

Vericore zirconia blanks are made from pre-sintered zirconium dioxide intended to be used with CAD/CAM or manual milling machines. Vericore zirconia blanks are biocompatible and designed to fabricate;

• -Zirconia Substructures
• Restorations (Including inlays, onlays, and veneers) -
• -Crown Framework in the Anterior and Posterior regions
• -Bridge Framework in the Anterior and Posterior regions

Vericore Zirconia Blanks is a device made from pre-pressed and pre-sintered zirconia powder. It is available in various shades, shapes, and sizes to accommodate the customers CAD/CAM or manual milling equipment/strategies and is not machine specific. Vericore Zirconia Blanks are made from a biocompatible zirconia powder. It is intended to be used by professionals for the fabrication of dental restorations.

The provided document is a 510(k) summary for a medical device (Vericore Zirconia Blanks), which primarily focuses on establishing "substantial equivalence" to a predicate device rather than presenting a detailed clinical study for novel device performance. Therefore, many of the requested fields related to clinical study design (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance with AI) are not applicable or findable in this type of submission.

However, I can extract information related to acceptance criteria, device performance, and limited testing details.

Here's the information based on the provided document:

Acceptance Criteria and Device Performance

Study Details

• Sample size used for the test set and the data provenance: Not explicitly stated for the "test set" in the context of a clinical performance study. The "test set" here refers to the samples of Vericore Zirconia Blanks that underwent bench testing. The provenance of these physical samples would be the manufacturer (Whip Mix Corporation).
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device is a material, and its performance is evaluated through physical and chemical property testing (bench testing) against international standards, not against expert human interpretations.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Performance is determined by objective measurements compared to standard thresholds, not by human adjudication of clinical outcomes.
• 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 not an AI-enabled diagnostic device.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI-enabled device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for the bench tests are the established performance requirements outlined in the ISO 6872 standard for dental ceramic materials and ISO 10993 for biocompatibility.
• The sample size for the training set: Not applicable. This device is a material, not a machine learning model.
• How the ground truth for the training set was established: Not applicable. No training set is involved for this device.

Additional Information from the document:

• Study Type: Bench testing (physical and chemical property evaluation) and comparison to a legally marketed predicate device to establish substantial equivalence.
• Predicate Device: White Peaks Copran ZR/Origin ZR (K092496).
• Basis for Biocompatibility: The document states, "No further biocompatibility tests are necessary because Whip Mix Vericore Blanks are made from the same powder as the predicate," which indicates a reliance on the biocompatibility testing performed for the predicate device (in accordance with ISO 10993-10, 10993-3, and 10993-5).

Ask a specific question about this device

The ComfortSoft® Soft Denture Liner System is intended for use as a long-term soft liner for removable dentures.

ComfortSoft® is a high pressure cured, silicone-based soft lining material for long-term use in removable dentures. ComfortSoft® is suitable for all PMMA-based dentures. Meets ISO 10139-2 and is a Shors A hardness Type A material. It is a, translucent, non-flowing, long-term soft silicone based liner. Use to reline, rebase or line new or existing dentures. ComfortSoft® Soft Denture Liner provides a cushion between the denture and the mouth tissues to aid in reducing sore spots, and allows improved adaptation to tissue contours thereby aiding in a comfortable fit of the denture.

Here's a breakdown of the acceptance criteria and study information for the ComfortSoft® Soft Denture Liner System 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 the sample sizes for the individual biocompatibility tests or the ISO 10139-2 testing. It only reports that these tests were "completed and passed."

The data provenance is not explicitly mentioned (e.g., country of origin). The studies appear to be pre-market bench and biological testing conducted by or for the manufacturer. No retrospective or prospective human clinical trial data is mentioned.

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

This information is not applicable. The evaluations conducted were physical and biological tests against established standards (ISO 10139-2) and biocompatibility guidelines, not subjective expert assessments of a test set. Ground truth was established by the specifications of the tests themselves.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluations were objective tests against standards rather than subjective expert assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on bench testing and biocompatibility.

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

This question is not applicable to a physical medical device like a denture liner. There is no algorithm involved.

7. The Type of Ground Truth Used

The ground truth used for performance validation was based on:

• International Standards: ISO 10139-2:2009 for material properties.
• Biocompatibility Guidelines: Established protocols for various toxicity and sensitization tests (e.g., MEM elution, Guinea Pig Maximization Sensitization).
• Manufacturer Specifications: For bond strength (at least 1 MPa).

8. The Sample Size for the Training Set

This information is not applicable. There is no machine learning "training set" for this type of device.

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

This information is not applicable for the same reason as point 8.

Ask a specific question about this device

Whip Mix Preppies Plus ® is a device used as part of a professionally administered prophylaxis treatment. It is used on the tooth surface prior to;

• . Restoration cementation.
• Acid etching procedures: .
  • o Sealants
  • Orthodontic brackets o
  • 0 Composite restorations

Whip Mix Preppies Plus is an innovative blend of polishing and cleaning agents including 2% Chlorhexidine Gluconate (CHG) relative to liquid component and is in a paste form. Each cup provides enough flour of pumice paste for a single use. Preppies Plus has no fluoride, oils, or added flavoring agents.

The provided text is a 510(k) summary for a dental abrasive polishing agent, Preppies Plus®. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria through quantitative metrics.

The document primarily focuses on demonstrating substantial equivalence to predicate devices, particularly regarding safety and intended use, rather than presenting a performance study with specific acceptance criteria and outcome metrics.

Here's a breakdown of what can be extracted from the text in relation to your request, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

• Cannot be provided: The document does not define specific quantitative acceptance criteria (e.g., minimum abrasive effectiveness, maximum sensitivity reduction, etc.) or report detailed performance metrics against such criteria. The "Substantial Equivalence" table compares device characteristics and intended uses, but not performance against pre-defined success/acceptance criteria.

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

• Cannot be provided: There is no mention of a "test set" in the context of a performance study. The document refers to "non-clinical tests for bio-compatibility performed," but no details on sample size, methodology, or data provenance (country of origin, retrospective/prospective) are given for these tests.

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

• Cannot be provided: Since no performance study utilizing a "test set" with ground truth is described, information about experts or their qualifications is absent.

4. Adjudication Method for the Test Set:

• Cannot be provided: As no performance study with a test set is detailed, there's no mention of an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No: The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it refer to AI assistance or human reader improvement with AI. This is a medical device, not an AI/software device in the context of diagnostic imaging.

6. Standalone (Algorithm Only) Performance Study:

• No: This is a physical dental product, not an algorithm. Therefore, a standalone algorithm-only performance study is not applicable and not mentioned.

7. Type of Ground Truth Used:

• Cannot be provided: No performance study establishing ground truth (e.g., pathology, outcomes data, expert consensus) is described for this device. The closest concept is the "known risks associated with chlorhexidine in the FDA database," used as input for a risk management process, but this is not establishing ground truth for device performance.

8. Sample Size for the Training Set:

• Not Applicable/Cannot be provided: This is a physical dental product, not a machine learning model, so there is no "training set" in that context.

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

• Not Applicable/Cannot be provided: As there's no training set, there's no method for establishing its ground truth.

Summary of Device Safety and Effectiveness provided in the document:

The document states that the safety and effectiveness are established through:

• The established use of chlorhexidine in medical device applications since the 1970s and in many dental applications.
• A thorough search of the FDA database for known risks associated with chlorhexidine, which informed their risk management process.
• Adherence to ISO 14971 for risk management, identifying and mitigating known hazards to an acceptable level.
• Comparison to their existing 510(k) exempt device (Preppies Flour of Pumice), with the only difference being the addition of 2% Chlorhexidine Gluconate (CHG).
• "Acceptable results of the non-clinical tests for bio-compatibility performed." (No details on what these tests were, their methodology, or results are provided).
• The conclusion that the new device "introduces no new risks and is considered substantially equivalent" to predicate devices.

In essence, this 510(k) summary primarily asserts substantial equivalence based on material composition (addition of CHG), intended use, and a risk management process, rather than presenting a detailed performance study with quantitative acceptance criteria.

Ask a specific question about this device

The Vericore Abutment is intended for use as an accessory to an endosseous implant to support a prosthetic device in a partially or completely endentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

The abutment is placed over the implant and is mounted on to the implant with an abutment screw.

This device is compatible with the following manufacturers' implant systems: Nobel Biocare, Southern Hexed, 3i, 3i Certain, Zimmer, Endopore, Nobel Replace, Southern Trilobe, Astra and Straumann.

This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional.

Angled abutments and narrow diameter implants are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant.

The Devices covered in this submission are abutments which are placed on the dental implant to provide support for a prosthetic restoration.

Vericore Abutments are made from Titanium grade Ti-6Al-4V. The abutment screws and are made from Titanium grade Ti-6A1-4V. The abutment is made to be placed over the implant and is mounted on to the implant with an abutment screw. The abutments are compatible with the following implant systems: Zimmer - Narrow, Regular, Wide Nobel Biocare - Narrow, Regular, Wide 3i - Regular Hexed 3i Certain - Narrow, Regular, Wide Southern Hexed - Narrow, Regular, Wide Endopore -- Narrow, Regular and 5mm Nobel Replace- Narrow, Regular, Wide and 6mm Southern Trilock - Narrow, Regular and Wide Astra - Narrow and Regular Straumann - Narrow, Regular and Wide

Here's a breakdown of the acceptance criteria and study information for the Vericore Custom Abutment in Titanium, based on the provided text:

Acceptance Criteria and Device Performance

Study Information

The provided document describes a premarket notification (510(k)) for a medical device, which primarily relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a de novo clinical study with specific acceptance criteria in the way a new drug or novel medical device might. Therefore, some of the requested categories are not directly applicable in the traditional sense of a clinical trial or AI performance study.

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

• Sample Size: Not specified for the fatigue testing. It refers to "the worst case scenario for each connection platform style." This implies a selection of representative abutment designs for testing, but not a large statistical sample of patient data.
• Data Provenance: Not specified. The testing was described as "conducted according to ISO 14801," an international standard, suggesting it was laboratory-based testing rather than data from human patients.

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)

• Not applicable. The "ground truth" here is based on engineering and materials science principles and international standards (ISO 14801) for mechanical performance, not expert human interpretation of medical data.

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

• Not applicable. This type of adjudication is relevant for human-interpreted medical image or diagnostic studies, not for the mechanical testing described.

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 medical device (dental implant abutment) and the submission details mechanical performance testing, not an AI-assisted diagnostic or interpretation tool.

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

• Not applicable. This device is a physical medical implant component, not an algorithm.

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

• The "ground truth" for the performance evaluation derives from established engineering principles, materials science specifications (Titanium grade Ti-6Al-4V), and an international standard for mechanical testing (ISO 14801). Compliance with these standards and comparison to a predicate device's measured performance serves as the basis for evaluation.

8. The sample size for the training set

• Not applicable. There is no concept of a "training set" in the context of this type of medical device submission.

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

• Not applicable. As there's no training set, this question is not relevant.

Ask a specific question about this device

The Vericore Abutment is intended for use as an accessory to an endosseous implant to support a prosthetic device in a partially or completely endentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

The abutment is placed over the implant and is mounted on to the implant with an abutment screw.

This device is compatible with the following manufacturers' implant systems: Branemark, Southern Hexed, 3i, 3i Certain, Zimmer and Endopore.

This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional. Also highly angled abutments (i.e. 15 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant.

Zimmer - Narrow, Regular, Wide Nobel Biocare - Narrow, Regular, Wide 3i -Micro Mini, Regular Hexed, 5mm 3i Certain - Narrow, Regular, Wide Southern Hexed - Narrow, Regular, Wide Endopore - Narrow, Regular and 5mm Astra - Narrow and Regular Straumann - Narrow, Regular, Wide

The Devices covered in this submission are abutments which are placed on the dental implant to provide support for a prosthetic restoration.

Vericore Abutments are made from biocompatible yttria-stablized zirconia blocks. The abutment screws are made from Titanium grade Ti-6A1-4V The abutment is placed over the implant and is mounted on to the implant with an abutment screw The abutments are compatible with the following implant systems:

Zimmer - Narrow, Regular, Wide Nobel Biocare - Narrow, Regular, Wide 3i -Micro Mini, Regular Hexed, 5mm 3i Certain - Narrow, Regular, Wide Southern Hexed - Narrow, Regular, Wide Endopore - Narrow, Regular and 5mm Astra - Narrow and Regular Straumann - Narrow, Regular, Wide

This is a medical device 510(k) premarket notification for a dental abutment, not an AI/ML device. Therefore, the requested information (acceptance criteria for AI/ML performance, study details for AI/ML validation, sample sizes for training/test sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, and standalone performance) is not applicable and cannot be extracted from the provided text.

The document discusses the substantial equivalence of the "Vericore™ Abutment" to previously marketed dental abutments, based on its materials, intended use, and compatibility with various implant systems. It's a traditional medical device submission, not involving AI or machine learning.

Ask a specific question about this device

The Vericore Abutment is intended for use as an accessory to an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. In is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

The abutment is placed over the implant and is mounted on to the implant with an abutment screw; an abutment adaptor will be added between the implant and the abutment. The abutment adaptor is intended to interface between the abutment and the implant allowing the abutment to meet with and be sealed to the parts of the implan that can not be milled into the abutment.

This device is compatible with the following manufacturers' implant systems: Nobel Biocare, Southern Trilock.

This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional.

Also highly angled abutments (i.e. 28 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended foor the posterior region due to limited strength of the implant.

Replace- Narrow (3.5mm), Regular (4.3mm), Wide (5.0mm) and 6mm Southern Trilock - Narrow (3.5mm), Regular (4.3mm) and Wide (5.0mm)

The Devices covered in this submission are abutments which are placed on the dental implant to provide support for a prosthetic restoration.

Vericore Abutments are made from biocompatible yttria-stablized zirconia blocks. The abutment screws and adaptors are made from Titanium grade Ti-6A1-4V for the screws and Grade 4 for the adaptors. The abutment is placed over the implant and is mounted on to the implant with an abutment screw; an abutment adaptor will be added between the implant and the abutment. The abutment adaptor is intended to interface between the abutment and the implant allowing the abutment to meet with and be sealed to the parts of the implant that can not be milled into the abutment. The abutments are compatible with the following implant systems:

Replace- Narrow (3.5mm), Regular (4.3mm), Wide (5.0mm) and 6mm Southern Trilock - Natrow (3.5mm), Regular (4.3mm) and Wide (5.0mm)

The provided text is a 510(k) summary for the Vericore™ Abutment, a dental implant abutment. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria, study methodologies, sample sizes, ground truth establishment, or expert qualifications that would typically be found in a study demonstrating device performance.

Therefore, I cannot provide the requested table and study details.

The document primarily focuses on:

• Device Description: What the Vericore Abutment is made of and how it functions.
• Intended Use: The clinical purpose of the abutment.
• Predicate Device: The legally marketed device (Atlantis Zirconia Abutments) to which equivalence is claimed.
• Regulatory Information: FDA’s determination of substantial equivalence and general controls applicable to the device.

There is no mention of any performance studies, clinical trials, or bench tests with specific acceptance criteria or results. The FDA's 510(k) clearance process for devices like this often relies on demonstrating substantial equivalence to a predicate device, sometimes through physical and mechanical testing, but the details of such testing (if performed and submitted) are not present in this summary.

Ask a specific question about this device