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FotoDent® denture is a light curing resin intended for manufacturing of full and partial removable dentures.

FotoDent® denture is a light curable resin for 3D printing of full and partial dentures.

The provided submission describes FotoDent® denture, a light-curing resin for 3D printing of full and partial dentures. This is a Class II device (21 CFR 872.3760).

1. Acceptance Criteria and Reported Device Performance

The device was tested against the applicable requirements of ISO 20795-1:2013 (Dentistry – Base polymers – Part 1: Denture base polymers) and ISO 7491:2000 (Dentistry – Dental materials – Determination of colour stability). The submission states that FotoDent® denture "met the applicable requirements" of these standards.

A direct comparison of physical properties between FotoDent® denture and the predicate device (DENTCA Denture Base II) is provided, which implicitly sets the acceptance criteria based on demonstrating "similar physical properties" to the predicate.

Note: The submission clarifies that "The differences in physical properties between FotoDent denture and the predicate device does not impact safety and effectiveness, as the finished clinical product is a custom-fitted denture base regardless of the material variation." This indicates that while some properties differ, they are deemed within an acceptable range for the intended use and do not negatively affect clinical outcomes compared to the predicate.

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

The submission mentions "Bench test results" and "Non-Clinical Performance Testing" and "Biocompatibility" testing.

• Sample Size: The document does not specify the sample sizes used for these tests.
• Data Provenance: The document does not specify the country of origin of the data or whether the tests were retrospective or prospective. Given these are bench tests and biocompatibility evaluations, they are inherently prospective.

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

Not applicable. The tests performed are non-clinical (bench tests and biocompatibility), and therefore do not involve human expert ground truth establishment in the way clinical studies with image interpretation or diagnosis would.

4. Adjudication Method for the Test Set

Not applicable. As described above, the tests are non-clinical, and thus an adjudication method for human interpretation is irrelevant.

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

No, an MRMC comparative effectiveness study was not done. The submission explicitly states under "Clinical Performance Data": "Not applicable. No human clinical testing was performed to support the substantial equivalence of FotoDent® denture."

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

Not applicable. FotoDent® denture is a physical material (resin) for 3D printing, not an algorithm or a software device that would have standalone performance.

7. The Type of Ground Truth Used

For the non-clinical performance and biocompatibility testing, the "ground truth" is established by the specifications and standard methodologies outlined in the referenced ISO standards (ISO 20795-1:2013, ISO 7491:2000, ISO 10993-1:2009, ISO 7405:2008). These standards define the acceptable range or characteristics for the material properties.

8. The Sample Size for the Training Set

Not applicable. As FotoDent® denture is a physical material, there is no "training set" in the context of machine learning or AI.

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

Not applicable, for the same reason as point 8.

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StoneBite® and StoneBite® scan are addition-curing silicones for bite registrations.

StoneBite® is indicated for:

• bite registrations
• I key for intraoral registration

StoneBite® scan is indicated for:

• i bite registrations
• key for intraoral registration
• . optical collection of data in CAD/CAM/CIM systems

StoneBite and StoneBite scan are addition-curing silicones for bite registration, used in dental applications to produce an accurate reproduction of the patient's occlusal record.

StoneBite and StoneBite scan are vinyl polysiloxane based materials.

StoneBite and StoneBite scan are medium-body elastomeric bite registration materials for dental applications to produce an accurate reproduction of the patient's occlusal record. StoneBite and StoneBite scan are two-component (base and catalyst) additioncuring materials.

The document describes the non-clinical performance testing for dental impression materials, specifically StoneBite and StoneBite scan. This is not medical AI device and therefore does not contain any of information requested.

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Dynax® Dental Impression Material is intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums.

Dynax® Dental Impression Materials are designed for dental applications to define and reproduce the structure of a patient's teeth and gums for producing crowns, bridges, occlusal and dental implant. Base and catalyst components are mixed in equal ratio 1:1, placed into an impression tray and inserted into the patient's mouth. The material will conform to the patient's dentition and when set will produce a reproduction of the patient's teeth and occlusion.

The acceptance criteria and study proving device performance are detailed below 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 size used for the test set. It mentions "a series of in-house tests have been conducted to verify the intended signals are accurate and can maintain performance over its useful life" and that the device meets its product specification.

The data provenance is not explicitly mentioned as country of origin, but the manufacturer is Dreve Dentamid GmbH, located in Unna/Germany. The testing appears to be "in-house."

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

This information is not provided in the document. The testing described focuses on physical and chemical properties of the impression material, not on interpretations by experts.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are not applicable or mentioned, as the testing relates to measurable physical properties rather than subjective interpretations by multiple experts.

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

No. The document presents a comparison of physical and chemical properties of the device with a predicate device. It does not describe an MRMC comparative effectiveness study involving human readers or AI assistance.

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

No. The device is a dental impression material, not an algorithm or AI. Performance is evaluated based on its physical properties.

7. The Type of Ground Truth Used

The ground truth for the device's performance is established by standardized physical and chemical property measurements, benchmarked against the acceptable ranges defined by the predicate device and relevant international standards (e.g., ISO 4823). These are objective measurements rather than expert consensus, pathology, or outcomes data in a medical diagnostic sense.

8. The Sample Size for the Training Set

This information is not applicable and is not provided. The development and testing of this dental impression material do not involve a "training set" in the context of machine learning or AI models.

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

This information is not applicable, as there is no training set for this type of device. The ground truth for the product's performance is derived from its adherence to documented specifications and international standards for dental impression materials.

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Varnish for final coating for resin temporaries to produce a smooth and shiny surface.

Dental sealing lacquer for coating resin temporaries

The light-curing one-component dental sealing lacquers NanoVarnish, Plaquit and Lightpaint on Surface are designed for coating resin parts of complete and partial dental prosthesis and for provisional crowns and bridges. The lacquer is applied to a dental restoration and cured with the help of a dental light-curing unit.

This document is a 510(k) premarket notification for a dental sealing lacquer. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of AI-powered device performance. Therefore, many of the requested criteria regarding AI acceptance, human readers, and ground truth for AI model training cannot be extracted from this document.

Here's what can be extracted based on the provided text:

Acceptance Criteria and Device Performance

For this type of device (a dental material), "acceptance criteria" are based on demonstrating comparable physical and chemical properties to a legally marketed predicate device, rather than accuracy metrics for an AI system. The study performed is a comparative study of the new device against a predicate device.

Table of Acceptance Criteria and Reported Device Performance

Explanation of Differences (as stated in the document): The document explicitly states that "The difference of the Intended Use and the Indications for Use of the Dreve dental sealing lacquers (Plaquit, NanoVarnish and Lightpaint on Surface) and the predicate are due to the availability of the predicate K123761 VITA ENAMIC® Glaze in a set of devices." It clarifies that the Glaze material within the predicate's set is used "for coating purpose only" and provides "protection of the stains from abrasion wear." The document concludes that "The technological characteristics of the subject device and the predicate are virtually identical and both devices have generically the same intended use."

Information NOT available in the document (due to the nature of the device and the submission):

This document describes a conventional medical device (a dental varnish), not an AI/ML-powered device. Therefore, the following information, which is relevant for AI acceptance criteria, is not present and cannot be extracted:

2. Sample sizes for test set and data provenance: Not applicable. The "study" here is a set of comparable physical and chemical tests, not a clinical trial with patient data or an AI model's test set.
3. Number of experts and their qualifications for ground truth: Not applicable for a physical material. Ground truth in this context refers to standard measurements/tests.
4. Adjudication method for the test set: Not applicable.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable. This is for AI-assisted human performance studies.
6. Standalone (algorithm only without human-in-the loop performance): Not applicable as there is no algorithm.
7. Type of ground truth used: For a physical material, the "ground truth" is established through standardized laboratory testing and material characterization against defined specifications and recognized consensus standards (e.g., ISO standards for dental materials). The document states: "Testing has confirmed these devices meet their product specification."
8. Sample size for the training set: Not applicable. This document is not about an AI model.
9. How the ground truth for the training set was established: Not applicable.

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Fixtemp® C&B is a resin based material used to fabricate temporary crowns and bridges.

Fixtemp® C&B is a two-component automatically mixable composite on the basis of multifunctional (meth)acrylates provided in standard double cartridges. The material is dispensed and mixed by cartridge/mixing tip combination and it is used for the manufacturing of temporary crowns and bridges for use until the permanent restoration is fabricated. It can be also used for inlays, onlays and veneers and is available in tooth-colors A1, A2, A3, A3.5, B1, Bleach X and D2. This is a prescription only material. The labeling and working instructions are designed for health care professionals.

Acceptance Criteria and Device Performance for Fixtemp® C&B

The Fixtemp® C&B device is a resin-based material used to fabricate temporary crowns and bridges. Its performance was evaluated against a set of non-clinical criteria to establish substantial equivalence to a predicate device.

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 specific sample sizes used for each individual test (e.g., number of specimens for compressive strength). It generally refers to "a series of in-house tests" and adherence to specific ISO standards (e.g., DIN EN ISO 4049:2010).

For the cytotoxicity testing, the test was conducted by the independent laboratory Toxikon Europe. The provenance of the data is indicated as "Toxikon Europe Final GLP Report: 17-01389-G1". The country of origin for the manufacturing company (Dreve Dentamid GmbH) is Germany. It is implied that these are prospective tests performed on the Fixtemp® C&B material.

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

This information is not provided in the document. The performance evaluation relies on standardized tests (e.g., ISO standards) and laboratory findings rather than expert consensus on a test set in the typical sense of diagnostic imaging or clinical studies. The cytotoxicity test was conducted by an "independent laboratory," but the qualifications of the individuals establishing the ground truth (i.e., interpreting the cytotoxicity results) are not detailed.

4. Adjudication Method for the Test Set

Not applicable. The reported tests are objective measurements based on standardized procedures and laboratory analysis, not subjective interpretations requiring adjudication by multiple experts.

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

No MRMC comparative effectiveness study was done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data. Fixtemp® C&B is a material for fabricating dental prosthetics, and its performance is evaluated through material properties and biocompatibility, not reader interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. Fixtemp® C&B is a dental material, not an algorithm or software. Its performance is inherent to its physical and chemical properties.

7. The Type of Ground Truth Used

The ground truth for the performance tests consists of:

• Standardized measurement directly from testing: This applies to properties like working time, curing time, setting time, hardness, compressive strength, flexural strength, E-modulus, water absorption, and radiopacity, where the "ground truth" is a measured physical or chemical property that meets or exceeds a predefined numerical threshold from an established standard (e.g., DIN EN ISO 4049:2010).
• Laboratory findings: For cytotoxicity, the ground truth is established by the results of the ISO 10993-5 test conducted by an independent laboratory, indicating the absence of biological reactivity.
• Evaluations and assessments: For carcinogenic, mutagenic, and irritating/sensitizing potentials, the ground truth is based on "different evaluations and assessments" indicating no evidence of these effects within the specified time frame. While the specifics of these evaluations are not detailed, they likely rely on established toxicological principles and potentially other in-vitro or in-vivo studies not explicitly listed.

8. The Sample Size for the Training Set

Not applicable. Fixtemp® C&B is a physical material, not an AI model or software that requires a training set.

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

Not applicable, as there is no training set for this device.

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