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Meridian is a direct filling material for restoration of Class I to V cavities and for restoration of deciduous teeth.

Meridian is a light curing universal dental composite material of the latest nanohybrid type having an optimized chemical composition.

The provided text describes a 510(k) submission for a dental composite material named Meridian. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving novel performance against specific acceptance criteria using clinical studies with complex statistical methodologies often seen for other types of medical devices.

Therefore, many of the requested sections are not applicable to this type of device and submission. Based on the provided information, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

For this device, "acceptance criteria" are defined by the performance standards outlined in ISO 4049:2009 for polymer-based dental restorative materials, and the "reported device performance" demonstrates that Meridian meets these standards and is substantially equivalent to the predicate device (Tetric EvoCeram, K042819).

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

The document does not specify the sample sizes used for the in vitro tests conducted according to ISO 4049:2009 and ISO 10993. These are laboratory-based material tests, not clinical studies involving patient data. Therefore, concepts like "country of origin of the data" or "retrospective or prospective" are not applicable.

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

Not applicable. The ground truth for this device is based on standardized laboratory testing protocols (ISO 4049:2009, ISO 10993), not on expert consensus or clinical interpretation.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for interpretation of results, typically involving human readers. This device underwent in vitro material 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 a dental composite material, not an AI-powered diagnostic device. No MRMC studies were performed.

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

Not applicable. This is a material, not an algorithm.

7. The type of ground truth used

The ground truth used for this device is the physical and chemical properties of the material as measured by standardized, objective laboratory tests defined by international standards (ISO 4049:2009 for performance, ISO 10993 for biocompatibility). The comparison is against the predicate device, showing "substantial equivalence" based on these measurements.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set. The "training" for this device involved meeting established material standards.

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

Not applicable. As above, this is not an AI/ML device.

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LATIT FLOW is to be used as a filling material for restoring function to teeth that have lost portions due to caries:

Direct, fixed restorations, placed by the dentist after removal of carious tissue. Anterior restorations, Class III, IV Class V restorations, cervical caries, root erosion, wedge shaped defects. Small posterior restorations, Class I. Mini cavities, minimal invasion dentistry Veneering of discolored anterior teeth Splinting of mobile teeth. Preventive restorations in molars and premolars. Repair of composite and ceramic veneers. Luting of porcelain and composite veneers As first layer of Class I or II restorations

Contra indications:

The placement of LATIT FLOW is contraindicated

If a dry working field cannot be established or if the stipulated technique cannot be applied.

If the patient is known to be allergic to the components of LATIT FLOW.

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I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) clearance letter from the FDA for a dental filling material named "LATIT FLOW."

This type of document primarily confirms that the FDA has determined the device is substantially equivalent to a predicate device already on the market, based on its intended use and submitted information. It does not typically include detailed reports of performance studies, acceptance criteria, sample sizes, expert qualifications, or ground truth establishment.

The document lists the device's indications for use and contraindications, but it does not provide:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance for a test set.
• Details about experts or adjudication methods for ground truth.
• Information about MRMC studies or effect sizes.
• Standalone algorithm performance.
• Ground truth types.
• Training set sample sizes or how their ground truth was established.

Therefore, I cannot fulfill your request with the given input.

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MICROHYBRID 11 is to be used as a filling material for restoring function to teeth that have lost portions due to caries:

Direct, fixed restorations, placed by the dentist after removal of carious tissue. Anterior restorations, Class III, IV

Class V restorations, cervical caries, root erosion, wedge shaped defects.

Posterior restorations, Class I, II.

Splinting of mobile teeth.

Preventive restorations in molars and premolars.

Repair of composite and ceramic veneers.

Inlays/onlays with extra-oral post tempering

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I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is an FDA 510(k) premarket notification letter for a dental device called "Microhybrid 11," primarily focusing on its substantial equivalence determination. It lacks details about performance studies, acceptance criteria, sample sizes, ground truth establishment, or expert involvement.

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MICROFILL 13 is to be used as a filling material for restoring function to teeth that have lost portions due to caries: Direct, fixed restorations, placed by the dentist after removal of carious tissue. Anterior restorations, Class III, IV and V Corrections of anomalies such as peg shaped teeth Splinting of mobile anterior teeth. Repair of resin and ceramic veneers. Reconstruction of anterior trauma cases Veneering of discolored anterior teeth

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The provided text describes a 510(k) premarket notification for a dental device called "Microfill 13." However, it is a regulatory document and does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide information about the study design elements you asked for. The document solely focuses on the FDA's determination of substantial equivalence to a legally marketed predicate device, allowing "Microfill 13" to be marketed.

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MICRCHYBRID 12 is to be used as a filling material for restoring function to teeth which have lost portions due to caries:

IDirect, fixed restorations, placed by the dentist after removal of carious tissue. Anterior restorations, Class III, IV

Class V restorations, cervical caries, root erosion, wedge shaped defects.

Posterior restorations, Class I, II.

Splinting of mobile teeth.

Preventive restorations in molars and premolars.

Repair of composite and ceramic veneers.

Inlavs/onlays with extra-oral post tempering

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding a dental product, MICROHYBRID 12. It does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The document primarily focuses on:

• The FDA's determination of substantial equivalence to a predicate device.
• Regulatory classifications and requirements.
• Indications for use and contraindications for the dental filling material.

Therefore, I cannot provide the requested information, including the table of acceptance criteria, study details, sample sizes, ground truth establishment, or MRMC comparative effectiveness study results, as this information is not present in the provided text.

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E.TCHING 15 is used in the enamel or total etch techniques for Composite restorations Adhesive cementation of inlays (composite and ceramic)crowns, bridges, eneers, adhesive bridges and root posts. Splints Bonding of orthodontic attachments Fissure sealings

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This document is a 510(k) premarket notification letter from the FDA to AB Ardent for their device ETCHING 15. It details the regulatory approval process and general controls applicable to the device. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

Therefore, I cannot provide the requested table or information based on the provided text.

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ADHESIVE 14 is to be used as a bonding agent for light curing composites and compomers to dentine tooth structure.

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The provided text is a 510(k) clearance letter from the FDA for a dental bonding agent, Adhesive 14. It does not contain any information regarding acceptance criteria or a study demonstrating the device meets those criteria.

The document primarily focuses on establishing substantial equivalence to a predicate device and regulatory compliance requirements. It does not include:

• A table of acceptance criteria or reported device performance.
• Details about sample sizes, data provenance, expert qualifications, or adjudication methods for a test set.
• Information about MRMC studies, standalone algorithm performance, or ground truth types.
• Details about training set size or how its ground truth was established.

Therefore, I cannot fulfill the request using the provided text.

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HIGH SILVER CONVENTIONAL is to be used as a filling material for restoring function to teeth which have lost portions to caries:

Direct, fixed restorations, placed by the dentist after removal of carious tissue.

Single surface cavities such as Class I

Two surface cavities such as MO, DO, FO, LO

Three surface cavities such as MOD, FOD.

Pinned onlays and half crowns.

Core build-ups for cast half and full crowns.

For use only by dental professional such as DDS or DMD. Not for use by general public or OTC.

HIGH SILVER CONVENTIONAL

I am sorry, but the provided text does not contain the acceptance criteria or a study that proves the device meets specific acceptance criteria in the format you requested. The document is a 510(k) premarket notification letter from the FDA to AB Ardent regarding their "High Silver Conventional" amalgam alloy.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements. It also includes an "Indications for Use" section for the device. However, it does not detail specific performance metrics, acceptance criteria, or a study methodology that would allow me to populate the table and answer the study-related questions.

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FUTURA TOPCAP non gamma-2 is to be used as a filling material for restoring function to teeth which have lost portions to caries:

Direct, fixed restorations, placed by the dentist after removal of carious tissue.

Single surface cavities such as Class I

Two surface cavities such as MO, DO, FO, LO

Three surface cavities such as MOD, FOD.

Pinned onlays and half crowns.

Core build-ups for cast half and full crowns.

For use only by dental professional such as DDS or DMD. Not for use by general public or OTC.

Labels will bear this caution.

Not Found

This document is a 510(k) clearance letter from the FDA for a dental filling material called "Futura Topcap Non Gamma-2". It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory information and indications for use. Therefore, I cannot extract the requested information from the provided text.

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FUTURA GLASS IONOMER SILVER REINFORCED RESTORATIVE is to be used as a base, lining and filling material for restoring function to teeth which have lost portions to caries:

• Class I and II cavities in deciduous teeth.
• Repair of amalgam restored teeth (fractured restoration or tooth).
• Class I and II cavities in selected permanent teeth.
• Lining under amalgam or posterior composite restorations.
• Cavities where radiopacity is a prime requirement.
• Core build up material under crowns.
• On root surface for locating overdentures.
• Long term temporary replacement of cusps
• Repairs to crown margins.

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I'm sorry, but the provided text does not contain the information requested about acceptance criteria and a study proving a device meets those criteria. The document is an FDA 510(k) clearance letter for a dental restorative material (Futura Glass Ionomer Silver Reinforced Restorative), indicating that the device is substantially equivalent to a legally marketed predicate device.

The information you've requested typically involves performance data, study designs, sample sizes, and expert qualifications, which are not detailed in this regulatory clearance letter. This letter primarily confirms that the device can be legally marketed based on its equivalence to existing products, rather than providing a comprehensive report on its clinical performance and the studies used to establish specific performance criteria.

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