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Versa-Link Porcelain Bonding System is indicated for the adhesive cementation/bonding of all-ceramic dental restorations (veneers, inlays, onlays and crowns) composed of feldspathic porcelain, pressed porcelain and in-office machined ceramics.

A secondary indication is for the adhesive repair of fractured or damaged metal-ceramic units intraorally.

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The provided text is a 510(k) clearance letter from the FDA for a dental bonding system. It does not contain any information about the acceptance criteria, study details, or performance evaluation of a device as requested in the prompt.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

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Silgimix™ is indicated for use as a dental impression material. The material is intended primarily for taking impressions for study models, orthodontic models, counter impressions, partial denture impressions and temporary crown fabrication.

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This document is a 510(k) clearance letter for a dental impression material named Silgimix®. As such, it does not contain the kind of detailed study information (acceptance criteria, sample sizes, ground truth establishment, expert qualifications, etc.) that would be found in a clinical study report for an AI/ML medical device.

The FDA's 510(k) clearance process for devices like this typically relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials with the specific metrics you've requested for AI device studies.

Therefore, I cannot provide the requested information because it is not present in the provided document. The document primarily focuses on regulatory clearance and the device's intended use.

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Sultan Genie Magic Mix™ Ultra Hydrophilic Impression Material is intended for use as a dental impression material, compatible with all techniques including dual-phase, monophase and dual impression techniques. The material is dispensed from an automatic mixing machine system and placed into dental impression trays (metal or plastic) and is used to accurately reproduce intra-oral structures (teeth & gums) to provide models for study and/or fabrication of prosthetic devices.

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I am sorry, but the provided text does not contain information about the acceptance criteria or study details for a device. The document is a 510(k) clearance letter from the FDA for a dental impression material, outlining its substantial equivalence to a predicate device and its intended use. It does not include performance metrics or study designs.

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Sultan Genie Ultra Hydrophilic Impression Material is intended for use as a dental impression material. The material is dispensed from an automatic mixing cartridge system and placed into dental impression trays (metal or plastic) and is used to accurately reproduce intra-oral structures (teeth & gums) to provide models for study and/or fabrication of prosthetic devices.

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This is a 510(k) clearance letter from the FDA for Sultan Genie™ Ultra Hydrophilic Impression Material, classifying it as substantially equivalent to a predicate device. This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner typically expected for an AI/ML medical device.

The provided text pertains to a traditional dental impression material, not an AI/ML-based device. Therefore, the details requested (such as sample size for test/training sets, expert qualifications, HRMC studies, standalone performance, etc.) are not applicable to this submission.

The "acceptance criteria" and "study" mentioned in the context of this document would refer to the standards for dental impression materials (e.g., rheology, dimensional stability, tear strength, hydrophilic properties, biocompatibility) and the non-clinical bench testing or potentially limited clinical evaluations demonstrating that the Sultan Genie™ material performs comparably to the identified predicate devices for its intended use.

Based on the provided text, I cannot furnish the requested information because it is not an AI/ML device submission.

However, I can extract the relevant information from this document:

• Device Name: Sultan Genie™ Ultra Hydrophilic Impression Material
• Intended Use: As a dental impression material, dispensed from an automatic mixing cartridge system, placed into dental impression trays (metal or plastic) to accurately reproduce intra-oral structures (teeth & gums) to provide models for study and/or fabrication of prosthetic devices.
• 510(k) Number: K030414
• Regulatory Class: II
• Product Codes: ELW

To reiterate, the questions posed in your prompt (e.g., sample size for test set, expert qualifications, MRMC study, standalone performance) are designed for AI/ML device submissions, which this document is not.

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Sultan Sporox Test Vials are indicated as a rapid, qualitative method for determining if an effective concentration of hydrogen peroxide is present in Sporox Sterilizing and Disinfecting Soution. The Sporox Test Vials indicate the concentration of hydrogen peroxide but do not confirm disinfection or sterilization.

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The provided text is a 510(k) clearance letter from the FDA for a device called "Sultan Sporox Test Vial, Model 75195." This document grants market clearance based on substantial equivalence to predicate devices. It does not present a study or acceptance criteria for a new device's performance in the way a clinical trial report or a performance study summary would.

Therefore, I cannot extract the requested information using the format specified in your prompt because the provided document does not contain:

• A table of acceptance criteria and reported device performance.
• Details about a test set, data provenance, or sample sizes for testing or training.
• Information on expert ground truth establishment or adjudication methods.
• Results from multi-reader, multi-case (MRMC) comparative effectiveness studies.
• Details about standalone algorithm performance studies.
• Specific types of ground truth used (beyond implying the test vials detect hydrogen peroxide concentration).

The document is a regulatory approval, confirming that the device is "substantially equivalent" to existing devices already on the market. It doesn't detail the performance studies that would typically be required for a novel device or for establishing performance criteria beyond what is already accepted for the predicate device.

To answer your prompt, I would need a document that describes the design and results of a performance study for the device, including specific metrics, methodologies, and outcomes.

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Pro-Portion is a general-purpose cleaner/disinfectant. Its use is restricted to a health care setting where low and intermediate level disinfection of hard, non-porous surfaces is required. It is intended to be used in a dental office as an instrument ultrasonic cleaning solution. In order to disinfect, a contact time of 10 minutes at 69°F / 20°C is required.

This product may be used to pre-clean or decontaminate of critical or noncritical medical devices prior to sterilization. Must be followed by appropriate terminal sterilization or high-level disinfection process.

Pro-Portion is a broad spectrum, multi-purpose ready to use, effective cleaner and disinfectant for use on the surfaces of inanimate objects. Pro-portion will efficiently clean and disinfect, when used as directed, such items as laminated counter tops, dental units, dental instruments, lights, and other inanimate surfaces, including those made of plastics (such as: polycarbonate, polyvinylchloride, polypropylene and polystyrene), nonporous vinyl and upholstery, stainless steel, painted surfaces, Plexiglas, glass, and other hard non-porous surfaces.

The provided text is a 510(k) summary for a phenolic cleaner/disinfectant called Pro-Portion. It outlines the product's physical characteristics, intended use, and ultimately states that the FDA found it substantially equivalent to legally marketed predicate devices.

However, the document does not contain information about acceptance criteria, a study that proves the device meets those criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to the performance of a device in terms of clinical or diagnostic outcomes.

This document is for a disinfectant, which is a chemical product rather than a diagnostic or therapeutic medical device that would typically involve a "study" with "acceptance criteria" for performance metrics like sensitivity or specificity. The "performance characteristics" mentioned refer to its efficacy as a cleaner and disinfectant against microorganisms, which are typically evaluated through standardized microbiological tests, not studies involving human subjects or expert consensus on interpretations.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving the device meets them, as that information is not present in the provided text for this type of product.

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Intended to reline a denture surface that contacts tissue--for temporary or provisional usage. Not for OTC use.

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I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or details of a study that proves a device meets acceptance criteria. The document is a 510(k) premarket notification approval letter for a dental device called "Dinabase™", indicating that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. It also includes the intended use of the device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the given information.

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