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HYDRORISE is conventional two-component (base/catalyst) polyvinylsiloxane (VPS) dental impression material intended to be placed on a preformed impression tray and used to reproduce the structure of a patient 's teeth and gums.

HYDROSYSTEM, an accessory to Hydrorise dental impression material, is intended to be applied to conventional substrates, including tooth preparations, ceramics, composites, metal core build-up material, and provides a uniform surface wetting with reduced surface tension beliore applying traditional dental impression material.

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I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets those criteria.

The document is a 510(k) premarket notification letter from the FDA to Zhermack S.P.A. for their devices HYDRORISE and HYDROSYSTEM. It states that the devices are substantially equivalent to legally marketed predicate devices. It also outlines regulatory requirements such as registration, labeling, and good manufacturing practices.

Specifically, the document contains:

• Dates: March 26, 2009 (FDA letter date), March 17, 2009 (Applicant's letter date), March 19, 2009 (Received date), November 03, 2008 (HYDRORISE revision date).
• Device Names: HYDRORISE and HYDROSYSTEM.
• Regulation Number: 21 CFR 872.3660 (Impression Material).
• Regulatory Class: II.
• Product Code: ELW.
• Indications for Use:
  • HYDRORISE: "conventional two-component (base/catalyst) polyvinylsiloxane (VPS) dental impression material intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums."
  • HYDROSYSTEM: "an accessory to Hydrorise dental impression material, is intended to be applied to conventional substrates, including tooth preparations, ceramics, composites, metal core build-up material, and provides a uniform surface wetting with reduced surface tension before applying traditional dental impression material."

There is no mention of:

• Acceptance criteria for performance.
• Any study (e.g., clinical, technical) conducted by the manufacturer to demonstrate performance.
• Sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for any such study.

Therefore, I cannot provide a table of acceptance criteria and device performance, nor can I describe study details as requested.

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COLORISE RIGID is a conventional two-component (base/catalyst) polyvinylsiloxane (VPS) dental impression material intended to be placed on a preformed impression tray and used to reprocluce the structure of a patient's teeth and gums.

COLORISE RIGID is a conventional two-component (base/catalyst) polyvinylsiloxane (VPS) dental impression material.

I am sorry, but based on the provided text, I cannot provide details on the acceptance criteria and the study that proves the device meets those criteria.

The document is a 510(k) premarket notification letter from the FDA to Zhermack S.p.A. for their device named "COLORISE RIGID". This letter primarily states that the FDA has reviewed the submission and determined that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

While it mentions the device is an "impression material" and "intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums," the document does not contain any information regarding:

• Specific acceptance criteria for the device's performance.
• Details of any study conducted to demonstrate the device meets acceptance criteria.
• Sample sizes, data provenance, expert qualifications, or adjudication methods for a test set.
• Whether MRMC or standalone performance studies were done.
• The type of ground truth used or how ground truth for training data was established.

This document is an administrative approval letter, not a scientific study report or a detailed technical specification.

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Zhermack OCCLUFAST CAD is a dental impression material intended to be placed on a dental patient's teeth for bite registration to reproduce the structure of a patient's teeth to provide models for study or for production of restorative prosthetic devices.

Occlufast CAD has been developed for use with CAD/CAM systems.

dental impression material

The provided document is an FDA 510(k) clearance letter for a dental impression material named Occlufast® CAD. This type of document primarily confirms that a new device is "substantially equivalent" to a predicate device already on the market, based on its indications for use and sometimes on performance data.

However, the letter does not contain any information regarding specific acceptance criteria for device performance, nor details of a study that proves the device meets such criteria. It's a regulatory clearance, not a technical performance report.

Therefore, I cannot provide the requested information from the given text. The document does not describe:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for any test sets.
3. Number or qualifications of experts used for ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness studies.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document states that the FDA "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." This substantial equivalence determination typically relies on comparing the new device's technological characteristics and intended use to those of a predicate device, sometimes supported by basic performance testing to ensure safety and effectiveness are comparable, but detailed study reports and acceptance criteria are not typically included in the publicly available clearance letter itself.

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COLORISE is a conventional two-component (base/catalyst) polyvinylsiloxane (VPS) dental impression material intended and used to reproduce the structure of a patient`s teeth and gums.

COLORISE is a conventional two-component (base/catalyst) polyvinylsiloxane (VPS) dental impression material.

This document is a 510(k) clearance letter from the FDA for a dental impression material named COLORISE. It does not contain information about acceptance criteria or a study proving that the device meets those criteria. This type of information is typically found in the 510(k) summary or premarket notification submission itself, not in the clearance letter.

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

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FREEALGIN is a conventional two-component (base/catalyst) polyvinylsiloxane (VPS) dental impression material intended to be placed on a preformed impression tray and used to reproduce the structure of a patient`s teeth and gums.

FREEALGIN is a conventional two-component (base/catalyst) polyvinylsiloxane (VPS) dental impression material

Here's an analysis of the provided text regarding acceptance criteria and a study for the Zhermack SpA Freealgin device:

Important Note: The provided document is a 510(k) clearance letter from the FDA for a dental impression material. It does not contain details about a study proving device performance against acceptance criteria in the way one would describe for, say, an AI/ML medical device. Instead, it states that the device is "substantially equivalent" to a legally marketed predicate device. This implies that its performance is expected to be similar to that predicate device and that it meets the general requirements for its classification (Class II).

Therefore, I will interpret your request in the context of what can be inferred or is typically expected for a device like this, rather than a direct presentation of study results as you might find for a software algorithm. The document primarily focuses on regulatory approval based on substantial equivalence.

Analysis of Acceptance Criteria and Study (Based on 510(k) context)

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a dental impression material, the "acceptance criteria" are likely to be related to physical and mechanical properties that demonstrate its suitability for its intended use and similarity to predicate devices. The document does not explicitly state a table of acceptance criteria or performance results from a specific study.

However, based on the nature of a dental impression material, typical performance metrics and their implied "acceptance" would be:

Note: The FDA's substantial equivalence finding indicates that Freealgin is as safe and effective as a predicate device. This implies that any studies conducted by the manufacturer, while not detailed in this public document, would have demonstrated that Freealgin meets the expected performance characteristics of a conventional VPS dental impression material to a degree comparable to existing, legally marketed devices.

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

This information is not provided in the 510(k) clearance letter. For a dental impression material, testing would typically involve laboratory physical and mechanical property evaluations (e.g., measuring setting time, tear strength, dimensional stability, elastic recovery) and potentially ex-vivo or in-vitro models. The provenance of such data would be internal lab testing, likely conducted in an industrial setting, possibly at the manufacturer's R&D facilities.

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

This type of information is not applicable or provided in the context of this 510(k) clearance. "Ground truth" established by experts is typically for diagnostic devices or AI/ML algorithms where expert interpretation is key. For a dental impression material, "ground truth" would relate to objective physical and mechanical measurements, rather than expert consensus on interpretation.

4. Adjudication Method for the Test Set

This is not applicable or provided. Adjudication methods like 2+1 or 3+1 are used for expert consensus in diagnostic studies, which is not the nature of the evaluation for a dental impression material.

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 or mentioned. MRMC studies are generally performed for diagnostic imaging devices or software where human readers interpret medical images. This device is a physical dental impression material.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, this is not applicable. This device is a physical material, not an algorithm. Therefore, "standalone algorithm performance" is not a relevant concept here.

7. The Type of Ground Truth Used

For a dental impression material, the "ground truth" would be established by:

• Objective Laboratory Measurements: Using standardized test methods (e.g., ISO standards for dental impression materials) to measure properties like setting time, tear strength, dimensional accuracy, elastic recovery, Shore A hardness, etc.
• Biocompatibility Testing: In vitro assays for cytotoxicity, sensitization, and irritation.

8. The Sample Size for the Training Set

This information is not provided and is generally not applicable in the typical sense of AI/ML "training sets" for a physical medical device like an impression material. If "training set" refers to internal R&D iterations or optimization of the material formulation, that data would be proprietary and not included in a 510(k) clearance letter.

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

Again, in the context of a physical impression material, a "training set" with an associated "ground truth" doesn't fit the AI/ML paradigm. If interpreted as internal development and validation, the ground truth would be established through:

• Iterative Material Characterization: Scientists and engineers would formulate, test, and refine the material, comparing its physical and mechanical properties against desired specifications and existing predicate materials using the objective laboratory measurements described in point 7. This iterative process allows them to "train" their formulation to meet performance targets.
• Quality Control Standards: Establishing and adhering to strict quality control standards during manufacturing to ensure consistency of the product.

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Zhermack COLORBITE is a dental impression material indications Tor 650. of a patient's teeth.

COLORBITE is a dental impression material.

The provided text is a 510(k) premarket notification letter from the FDA regarding a dental impression material called "Colorbite." This document confirms that the device has been found substantially equivalent to predicate devices, allowing it to be marketed. However, this document does not contain information about acceptance criteria or a study proving the device meets those criteria.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials to establish acceptance criteria or performance metrics in the same way a PMA (Premarket Approval) might.

Therefore, I cannot provide the requested information based on the input text. The document does not describe:

• A table of acceptance criteria or reported device performance.
• Sample sizes or data provenance for any test set.
• The number or qualifications of experts for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) studies or effect sizes.
• Standalone performance studies.
• The type or method for establishing ground truth for any set.
• Sample size or ground truth establishment for a training set.

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ELITE IMPLANT is a radiopaque dental impression material intended to be placed on a preformed impression tray and used to reproduce the structure of a dental patient's teeth. Additionally, it is intended to provide models for study and for the production of restorative prosthetic devices, such as dental inlays and onlays. Its radiopacity is intended to assist in detecting possible fragments of residual material.

ELITE IMPLANT is a radiopaque dental impression material.

This document is a 510(k) clearance letter from the FDA for a dental impression material named "Elite Implant." It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter acknowledges that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information.

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Zhermack HYDROGUM 5 is a dental impression material intended to be placed on a preformed tray and used to reproduce the structure of a patients teeth, inlays and dentures. It is also intended to provide models of outletted in as dental inlays and dentures.

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This document is a 510(k) premarket notification from the FDA and does not contain the specific information requested about acceptance criteria and a study that proves the device meets those criteria.

The document states that the FDA has reviewed the 510(k) submission for the "Hydrogum 5" dental impression material and determined it is substantially equivalent to legally marketed predicate devices. This means the device is considered as safe and effective as other similar devices already on the market, but it does not provide details of specific performance criteria or a study proving it meets them.

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

Ask a specific question about this device

Ask a specific question about this device