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For the temporary displacement of the marginal gingiva and drying of the gingival sulcus, e.g. for

• conventional or digital impressions,
• cementation of temporary and permanent restorations
• and the creation of Class II and V fillings.

RetraXil belongs to the group of dental retraction material, mainly as cords (threads) with astringent agents. The retraction material is also marketed in form of a paste as alternative to the cords. RetraXil is a retraction paste containing aluminium chloride as astringent agent, which serves as hemostatic agent.

RetraXil is marketed as a gingival retraction paste with no hints of performance or safety issues for patients and users.

Retraxil is a retraction paste stored in a 1g syringe with a cannula and twisting aid.

N/A

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Signum metal bond:

• Bonding agent between framework surfaces made of metal alloys (precious metal, non-precious metal or titanium) and (meth-) acrylate-based veneering materials in conjunction with micromechanical retention.
• Bonding agent between partial framework surfaces made of metal alloys (precious metal, nonprecious metal or titanium) and (meth-) acrylate-based veneering materials or denture base materials (hot or auto-polymerizates).
• Bonding agent for extraoral repair of metal supported composite veneers.

Signum universal bond:
Metal

• Bonding agent between framework surfaces made of metal alloys (precious metal, non-precious metal or titanium) and (meth-) acrylate-based veneering materials in conjunction with macromechanical retentions.
• Bonding agent between partial framework surfaces made of metal alloys (precious metal, nonprecious metal or titanium) and (meth-) acrylate-based veneering materials or denture base materials (hot or auto-polymerizates).
• Bonding agent for the extraoral repair of metal-supported composite veneers.
  Zirconium dioxide
• Bonding agent between frameworks, implant abutments and single crowns made of ZrO3 and lightcuring veneering materials.
• Bonding agent for the extraoral repair of composite veneers on ZrO2 frameworks.
  High performance polymers (PEEK)
• Bonding agent between frameworks, implant abutments and individual crowns made of high performance polymers and light-curing veneering materials.
• Bonding agent between partial framework surfaces made of high-performance polymers and lightcuring veneering materials or denture base materials (hot or auto-polymerizate).
• Bonding agent for the extraoral repair of composite veneers on PEEK frameworks.

Signum liquid:
For light-curing veneering materials from Kulzer:

• Restoring the dispersion layer of light curing veneering materials.

Signum composite / Signum composite flow / Signum matrix:
Suitable for veneering the following dental framework materials: Metal alloys (precious metal, non-precious or titanium), zirconia, high-performance polymers (PEEK)
Suitable for partial alteration of the colour and shape of the following dental materials:
• PMMA
• Photopolymers
Suitable for the following prosthetic restorations:
• full and partial veneers for permanent framework-supported crowns and bridges
• veneering removable combination prosthetics (telescopic and tapered crowns and at-tachment prosthetics)
• veneering of superstructures/tertiary structures on implants
• metal-free front tooth and posterior tooth temporary restorations
• alteration of the colour and shape of Kulzer acrylic denture teeth
• alteration of the colour and shape of acrylic-based frameworks (PMMA).
• alteration of the colour and shape of Kulzer photopolymers that are approved for char-acterisation with Signum components (according to the photopolymer instructions for use)

Signum cre-active:
Individual characterization (e.g., of enamel cracks, white spots, imitation fillings, enamel wedges, intermediate colour layers, abrasion surfaces, fissures) of
• light-curing Kulzer veneering materials,
• Kulzer denture acrylic teeth and PMMA,
• (meth-)acrylate-based 3D printing photopolymers in accordance with the photopolymer instructions for use

Signum Bondings (Signum metal bond) are intended for dental works in the laboratory as an adhesion promoter between a given framework made of zirconium dioxide, dental alloys, high performance composites, PMMA, and a second material (e.g. composites or acrylics). These primers are only applied in the laboratory. After restorative work, Signum bondings are encapsulated between framework and the restoration/veneering material and a direct contact to the patient is very unlikely. Signum metal bond is a liquid stored in a 5 mL bottle with dropper and red cap.
Signum universal bond is a liquid stored in a 5 mL bottle with dropper and blue cap.
Signum liquid is indicated for light-curing materials from Kulzer to simplify modeling procedures and restore the dispersion layer of light-curing veneering materials.
Signum liquid is foreseen for dental works in the laboratory, where an adhesion promoter between a given composite layer and a second acrylate based material, including procedures is necessary. After completion of the restorative work, Signum liquid is encapsulated between both layers and a direct contact to the patient is very unlikely. Signum liquid is a liquid stored a 5 mL bottle with a spout and red cap.
Signum composite, Signum composite flow, and Signum matrix are veneering composites for crowns and bridges. The veneering composites are processed by dental technicians for dental restoration by veneering framework supported restorations (for example metal or zirconia frameworks).
After light activated polymerization is inserted into the oral cavity of a specific patient as a custom made device, adapted and connected to the remaining residual teeth or functionally adapted.
The veneering composites are pastes stored in a syringe featuring a plunger and a closing cap.
Signum cre-active are a light-curing color fluids for crown and bridge techniques and prosthetics.
Signum cre-active is used in the dental laboratory to create customized characterizations of dental prosthetic works, that are then inserted into the oral cavity of a specific patient as individualized medical devices, adapted, and connected to the remaining residual teeth or functionally adapted to the edentulous alved Signum cre-activelayers must be covered with veneering material, there is no direct patient contact.
Signum cre-active are liquids stored in a syringe featuring a plunger and a closing cap.

This is a 510(k) summary for a dental device, not a diagnostic AI/ML device. Therefore, the common acceptance criteria and study attributes for AI/ML devices, such as sensitivity, specificity, MRMC studies, ground truth establishment, expert qualifications, and training/test set sizes, are not applicable here.

This document describes the equivalence of several dental materials (Signum composite flow, Signum universal bond, Signum metal bond, Signum composite, Signum matrix, Signum liquid, Signum cre-active) to previously cleared predicate devices based on their intended use, technological characteristics, and performance data from non-clinical testing and literature review.

However, I can extract information related to performance testing that was done and the "acceptance criteria" through a generalized understanding.

Performance Criteria and Device Performance (Generalized to Non-AI/ML Devices)

Study Details (as inferable for non-AI/ML medical devices):

1. Sample Size used for the test set and the data provenance: Not explicitly stated as "sample size for test set" in the context of an AI/ML device. For mechanical and thermal testing, the sample size would refer to the number of material specimens tested, but this is not disclosed. The data provenance includes "internal data and scientific literature."

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is not an AI/ML diagnostic device requiring expert-established ground truth. The "ground truth" here is the performance of the material against established standards for dental materials.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as this is not an AI/ML diagnostic device with expert adjudication.

4. 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/ML diagnostic device.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/ML device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this type of device, the "ground truth" or reference standard for performance is established through internationally recognized standards for dental materials (e.g., ISO standards) that dictate acceptable ranges for mechanical, physical, and chemical properties. The submission refers to "internal data" and "scientific literature" to support the safety and performance, implying adherence to these established benchmarks.

7. The sample size for the training set: Not applicable. This is not an AI/ML device.

8. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

Additional Information from the Document:

• Study Type: The submission relies on non-clinical in vitro testing (for mechanical and thermal properties) and a literature-based clinical evaluation for all components.
• "Clinical evaluation is based on internal data and scientific literature currently available." This indicates that no new prospective clinical trials were conducted for this 510(k) submission. Instead, the safety and effectiveness are supported by existing knowledge and data.
• Predicate Device Comparison: The "acceptance criteria" for demonstrating substantial equivalence are primarily met by showing that the new devices have similar intended uses, technological characteristics, and performance to legally marketed predicate devices, which have already demonstrated safety and effectiveness.
• Long-standing Market Presence: Many components ("Signum composite is marketed since 1999, Signum composite flow since 2011 and Signum matrix since 1999," "Signum metal bond is marketed since 2007, Signum universal bond since 2022 and Signum liquid since 1983," "Signum cre-active is marketed since 1991") have a long history of safe use, further supporting their equivalence.

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Photopolymer for 3D printing of individualized, provisional and permanent prosthetic works. Indications

• Long-term temporary restorations (up to 6 months),
• Teeth for removable dentures

dima Print Teeth & Temp is a photopolymer liquid for 3D printing of dental appliances. Its processing by dental healthcare professionals includes 3D printing, cleaning and curing. The final product produced by dental healthcare professionals will be an individual medical device for a special patient, inserted into the oral cavity, adapted and connected to the remaining residual teeth or functionally adapted to a given denture. Dima Print Teeth & Temp is offered in a range of colors.

The provided text is a 510(k) summary for the medical device "dima Print Teeth & Temp". It outlines the general regulatory information, device description, and indications for use. However, it does not contain the detailed information about acceptance criteria, device performance results, sample sizes, expert qualifications, ground truth establishment, or clinical study methodologies that would be expected for a comprehensive study proving the device meets acceptance criteria.

The document states:
"Testing of the physical characteristics as listed in the predicate comparison table was conducted to evaluate the performance of dima Print Teeth & Temp, according to requirements of ISO 10477 and ISO 22112. All requirements were met."

This statement confirms that testing was done and requirements were met, but it does not provide the specific details of the acceptance criteria or the reported performance values. It also explicitly states "Not Applicable" under "Clinical Tests Summary & Conclusions 21 CFR 807.92(b)", indicating that a clinical study of the type described in questions 5, 6, and 7 was not performed or not required for this 510(k) submission.

Therefore, based solely on the provided text, I cannot provide a detailed answer to all parts of your request. I will indicate where the information is not present.

Acceptance Criteria and Device Performance Study for dima Print Teeth & Temp

Based on the provided FDA 510(k) summary (K233868), the device "dima Print Teeth & Temp" was evaluated against performance requirements derived from ISO 10477 and ISO 22112. The summary confirms that "All requirements were met." However, the specific acceptance criteria and the reported numeric performance values are not detailed in this document.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that testing was "according to requirements of ISO 10477 and ISO 22112" and that "All requirements were met." However, the specific quantitative acceptance criteria (e.g., "flexural strength > Y MPa") and the measured device performance (e.g., "flexural strength = Z MPa") are not provided in this 510(k) summary. These details would typically be in the full submission documentation.

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

The document does not specify the sample size used for the performance testing.
The data provenance (e.g., country of origin, retrospective/prospective) is also not provided in this summary. These physical/material tests are typically conducted in a laboratory setting.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

This type of information is generally relevant for studies involving human interpretation (e.g., imaging devices) where expert consensus is needed for ground truth. For physical material properties testing (as indicated by the reference to ISO 10477 and ISO 22112), ground truth is established by standardized test methodologies and measurements, not by expert consensus on human data. Therefore, this question is not applicable in the context of the reported non-clinical testing.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used in studies where human readers provide subjective assessments that need to be reconciled for ground truth. This was a non-clinical, physical properties test.

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

No. The document explicitly states "Not Applicable" under "Clinical Tests Summary & Conclusions 21 CFR 807.92(b)". This indicates that a clinical study, including an MRMC study comparing human readers with and without AI assistance, was not performed or not required for this 510(k) submission for this device.

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

No. The device is a "photopolymer liquid for 3D printing of dental appliances," not an AI algorithm. Therefore, a standalone algorithm performance evaluation is not relevant. The device itself is the material.

7. The Type of Ground Truth Used

For the performance testing reported (physical characteristics according to ISO 10477 and ISO 22112), the ground truth is established by standardized laboratory testing procedures and direct physical measurements as defined by the referenced ISO standards. This is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. The device is a material, not a machine learning algorithm 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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Light curing one-component opaquer to mask framework structures. Signum opaque F is the opaquer component for veneering materials and denture base materials (heat/cold curing denture acrylics) offered by Kulzer.

Signum opaque F is a light-curing, one component opaquer used for extraoral color-masking of framework structures for crowns, bridges, and/or partial dentures. The veneering composites are processed by dental restoration by veneering framework-supported restorations, such as metal or zirconia frameworks.

Signum opaque F is a paste stored in a syringe featuring a plunger and a closing cap. The product is dispensed and is then applied with a disposable brush until the scaffolding frame is completely covered. After polymerization, the crown or bridge is inserted into the oral cavity, adapted and connected to the remaining residual teeth or functionally adapted.

The provided text describes the 510(k) premarket notification for a dental device called "Signum opaque F." However, it does not contain information about the acceptance criteria or the study that proves the device meets those criteria in the context of an AI/ML-driven medical device.

The document is a traditional 510(k) submission for a non-AI dental material (tooth shade resin material). It focuses on:

• Substantial Equivalence: Comparing the new device (Signum opaque F) to a legally marketed predicate device (VITA VM LC FLOW) in terms of indications for use, technological characteristics, and conformance to standards.
• Mechanical and Thermal Testing: Mentioning that these tests were performed (shear bond strength, shelf-life at differing temperatures) but without providing specific acceptance criteria or detailed results.
• No Clinical Study for Performance: Stating that a clinical investigation "is not necessary and the route for this clinical evaluation is literature based" because the product type (veneering composites) is "well-established."

Therefore, I cannot populate the table or answer the specific questions related to AI/ML device performance, test sets, ground truth establishment, expert adjudication, or MRMC studies, as this information is not present in the provided text.

The request's parameters (AI/ML context, ground truth, experts, MRMC, etc.) are generally relevant to submissions for AI/ML-enabled medical devices, which leverage algorithms that interpret or process medical data. The provided document concerns a dental material's physical and chemical properties and its intended use, not an AI's diagnostic or predictive performance.

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Extended fissure sealing First-layer lining for class I and class II cavities Class I, II, III and V direct restorations Repair of direct and indirect restorations in combination with a suitable adhesive Splinting loosened teeth resulting from trauma or periodontal associated events

Venus Bulk Flow ONE is a light curing, radio-opaque nano-hybrid composite. The uncured dental composite is introduced into the oral cavity to be applied and cured to the tooth structure or restoration pre-treated by the dentist, thus achieving the clinical benefit.

The provided text describes the regulatory submission for the Venus Bulk Flow ONE, a dental restorative material. It focuses on demonstrating substantial equivalence to a predicate device (Venus Diamond Flow, K091635) primarily through non-clinical bench testing. There is no information regarding AI/ML device acceptance criteria or performance.

Here's the breakdown of the information requested, based on the provided text:

1. Table of acceptance criteria and the reported device performance:

2. Sample sized used for the test set and the data provenance:

The document describes non-clinical bench testing according to ISO 4049:2019. It does not specify sample sizes for these tests. The data provenance is from internal studies conducted by Kulzer, LLC.

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 objective, quantifiable physical and chemical properties measured through laboratory bench testing according to international standards (ISO 4049:2019), not expert consensus.

4. Adjudication method for the test set:

Not applicable. The "test set" here refers to material samples undergoing laboratory characterization against predefined ISO standards.

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 restorative material, not an AI/ML diagnostic or assistive device. There were no human readers or AI assistance involved.

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

Not applicable. This is a dental restorative material, not an AI/ML algorithm.

7. The type of ground truth used:

The ground truth used for demonstrating device performance is based on the specified requirements of international standard ISO 4049:2019 for polymer-based restorative materials. These are objective, measurable physical and chemical properties.

8. The sample size for the training set:

Not applicable. This is a conventional medical device, not an AI/ML device that requires a training set. The "development" of the product involved modification of materials and composition, not training of an algorithm.

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

Not applicable. There is no training set for this device.

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