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The product is a self-curing composite for the fabrication of temporary crowns, bridges, inlays, onlays and veneers.

TempFIT Temporary Crown and Bridge Resin is a self-curing composite for the fabrication of temporary crowns, bridges, inlays, onlays and veneers. The mixing ratio, based on volume, base paste: catalyst paste =1:1 or 10:1. TempFIT Temporary Crown and Bridge Resin is delivered in a bio-cartridge. The curing mechanism between methacrylates is self-curing, which fundamentally belongs to free radical polymerization in reaction principle. Free radical polymerization typically occurs in unsaturated molecules containing double bonds. Both methacrylate resins in TempFIT Temporary Crown and Bridge Resin and silane coupling agents on filler surfaces contain numerous carbon-carbon unsaturated double bonds. When the two-component system is mixed, a redox reaction generates abundant free radicals that initiate the polymerization of these double bonds.

This FDA 510(k) clearance letter is for TempFIT Temporary Crown and Bridge Resin. It addresses the substantial equivalence of this device to a legally marketed predicate device (Luxatemp Ultra/Star, K101710).

However, this document does not describe the kind of AI/ML device study that would typically involve acceptance criteria related to accuracy, sensitivity, specificity, and the use of expert readers for ground truth establishment. Instead, it focuses on the equivalence of a dental biomaterial product based on its physical, chemical, and biological properties.

Therefore, I cannot directly extract the detailed information requested regarding acceptance criteria and a study proving device performance in the context of an AI/ML medical device. The document describes a non-clinical testing approach for a dental material.

Here's how I can address your request based on the provided text, while highlighting the limitations:

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing for a Dental Material):

Study Details (Non-Clinical for a Dental Material):

1. Sample size used for the test set and the data provenance:

   • The document mentions "test results demonstrated the qualification and substantial equivalence." However, it does not specify the sample sizes of the materials tested for each physical property.
   • Data Provenance: The tests were performed according to ISO 10477 and Internal standard SOP of the company (HUGE SOP). Given the submitter's location (Rizhao City, China), the testing was likely conducted in China. The study is a non-clinical, laboratory-based performance test, not involving patient data.

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

   • Not applicable in this context. The "ground truth" for chemical and physical properties are established through standardized laboratory measurement techniques as per ISO standards and the company's internal SOPs, not through expert human interpretation in the way AI/ML ground truth is established.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. This is a non-clinical material test, not a subjective human-reading assessment.

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:

   • No. This type of study is relevant for AI-assisted diagnostic devices. This submission concerns a dental biomaterial.

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

   • Not applicable. This is not an algorithm-based device.

6. The type of ground truth used:

   • The "ground truth" for the physical and chemical properties of the temporary crown and bridge resin are the established measurement protocols and thresholds defined by ISO 10477 and the company's internal SOPs. These are objective, quantitative measurements (e.g., MPa for flexural strength, µm/mm³ for water sorption).

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device that requires a training set. The "development" of the material would involve chemical formulation and iterative testing, but not a "training set" in the computational sense.

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

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

In summary, the provided FDA clearance letter demonstrates a material's safety and effectiveness through adherence to established material standards and comparison to a predicate device, rather than through an AI/ML performance study.

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Asiga DentaTOOTH is intended exclusively for professional dental work. Asiga DentaTOOTH is a 3D print resin indicated for the manufacturing of 3D printed temporary crowns, bridges, inlays, onlays and veneers.

DentaTOOTH is a resin material used by dental professionals for the manufacture of temporary dental restorations including temporary crowns, bridges, inlays, onlays and veneers. DentaTOOTH resin is available in six Vita shades A1, A2, A3, B1, B2, B3.

DentaTOOTH resins are used with digital light processing (DLP) based 3D printers to produce denture temporary dental restorations. DentaTOOTH resin has been validated for use with the Asiga Max Series and Pro Series printers for the manufacture of temporary dental restorations at 385nm wavelengths.

DentaTOOTH is a light-cure methacrylate-based resin with photoinitiator, UV absorber, dispersant and pigments. DentaTOOTH is a Type 2, Class 2 resin per ISO 10477:2020 and Type 1, Class 2, Group 2 resin per ISO 4049:2019.

DentaTOOTH has a shelf life of 36 months. The device may be stored in Asiga Max and Pro Series printers for up to 4 weeks with hood closed.

DentaTOOTH is compliant to ISO 10477:2020 and ISO 4049:2019 for polymer based crown and veneering materials, and polymer based restorative materials, respectively.

The provided FDA 510(k) clearance letter for DentaTOOTH is for a temporary crown and bridge resin, not an AI-powered diagnostic device. Therefore, the information requested regarding acceptance criteria and studies that prove the device meets these criteria (such as MRMC studies, ground truth establishment, expert consensus, etc.) are not applicable to this type of device.

The 510(k) summary clearly states:

• Device Name: DentaTOOTH
• Common Name: Temporary crown and bridge resin
• Classification Name: Crown And Bridge, Temporary, Resin
• Regulation Number: 872.3770 (which corresponds to Temporary Crown And Bridge Resin)
• Product Code(s): EBG

The documentation details non-clinical tests performed in accordance with specific ISO standards relevant to dental materials (ISO 10477:2020 for Polymer-based crown and veneering materials and ISO 4049:2019 for Polymer-based restorative materials). These tests evaluate material properties such as:

• Depth of cure
• Surface finish
• Flexural strength
• Water sorption
• Solubility
• Shade consistency
• Color stability
• Packaging validation
• Shelf life
• Biocompatibility (according to ISO 10993-1:2018)

The clearance is based on the substantial equivalence of DentaTOOTH's material properties and indications for use to legally marketed predicate devices, as demonstrated by these material-specific performance tests.

Therefore, I cannot provide a response to your numbered points as they are designed for the evaluation of AI/ML or diagnostic devices, which is not what DentaTOOTH is.

The questions you posed are typical for the regulatory review of Software as a Medical Device (SaMD) with AI/ML components, particularly those involved in image analysis or diagnosis where performance is measured by metrics like sensitivity, specificity, or reader agreement. DentaTOOTH is a material, not a software or diagnostic device.

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Indication for use:

• Temporary anterior and posterior crowns;
• Implant and abutment supported prosthetics;
• Partial, complete and hybrid denture prosthetics (base and teeth).

Not Found

This FDA 510(k) clearance letter pertains to dental materials (Temporary Crown And Bridge Resin) and does not contain any information about an AI/ML medical device, its acceptance criteria, or the study that proves the device meets those criteria.

Therefore, I cannot extract the requested information regarding:

• Acceptance Criteria Table: There is no mention of performance metrics like sensitivity, specificity, or AUC.
• Sample Size and Data Provenance: No details about test sets, training sets, countries of origin, or retrospective/prospective studies.
• Expert Ground Truth: No information about the number or qualifications of experts or how ground truth was established.
• Adjudication Method: No mention of 2+1, 3+1, or any other adjudication process.
• MRMC Study: No indication of a multi-reader, multi-case comparative effectiveness study or related effect sizes.
• Standalone Performance: No data on the algorithm's performance without human intervention.
• Type of Ground Truth: No mention of pathology, outcomes data, or expert consensus.
• Training Set Sample Size and Ground Truth Establishment: No information provided.

The document is solely a regulatory approval for a physical dental product, not a software or AI/ML device requiring performance evaluation against clinical ground truth.

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TEMP MASTER, PMMA-based dental resin developed by Taiwan Dental Materials CO., LTD. is a self-cured resin indicated for the fabrication of short-term restorations including temporary inlays, crowns, and bridges, which can protect or restore damaged teeth while permanent restorations are being prepared. It is a traditional auto-cured PMMA-based resin composed of powder and liquid. Polymerization occurs when the powder and liquid are mixed at room temperature.

TEMP MASTER, PMMA-based dental resin, is a self-curing (cold-cure) material designed to fabricate temporary crowns and bridges. It consists of two components: powder and liquid. Polymerization occurs when the powder and liquid are mixed at room temperature. Classified as a Type 1 (autopolymerizable) acrylic resin according to ISO 10477 standards, TEMP MASTER, PMMA-based dental resin provides reliable performance for temporary restorations.

This document describes a 510(k) premarket notification for a dental material, not an AI/ML powered device. Therefore, much of the requested information regarding AI/ML device studies (such as sample sizes for test and training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) is not applicable.

However, I can extract the acceptance criteria and reported device performance based on the provided bench testing information for the TEMP MASTER, PMMA-based dental resin.

Here's the information as it relates to the provided document:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: The document does not specify the exact sample sizes used for the bench tests. It only states that "the nonclinical tests conducted in accordance with ISO 10477 assessed the flexural strength, water sorption, and water solubility."
• Data Provenance: The bench testing was performed to support the 510(k) submission from "Taiwan Dental Materials CO., LTD." The data would therefore originate from Taiwan, likely conducted prospectively for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a dental material, and the performance is evaluated through objective physical and chemical bench testing against international standards (ISO 10477). There were no human experts involved in establishing a "ground truth" in the way it's understood for AI/ML diagnostic devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As this involves physical/chemical testing, there is no "adjudication method" in the context of human interpretation or consensus. The tests would be performed according to standardized protocols and the results measured objectively.

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 medical device (dental material), not an AI/ML algorithm requiring human interpretation.

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

Not applicable. This is a medical device (dental material), not an AI/ML algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for the device's performance is established by international standards for dental materials (ISO 10477). These standards define the acceptable ranges and methodologies for evaluating physical and chemical properties like flexural strength, water absorption, and water solubility.

8. The sample size for the training set

Not applicable. This is a medical device (dental material), not an AI/ML algorithm that requires a "training set."

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

Not applicable. This is a medical device (dental material), not an AI/ML algorithm.

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SprintRay Digital Temp is a light-curable resin indicated for the fabrication of individual and fixed temporary full single crowns, temporary partial crowns, and temporary bridges. The material is an alternative to traditional restorative dental material.

SprintRay Digital Temp is a photo-polymer methacrylate resin material used in conjunction with a 3D printer and a scanned 3D image in a dental office to build dental prosthetics by 3D printing layer of the composite material. SprintRay Digital Temp resin is offered in various shades such as Bleach, A1, A2 and B1. Digital Temp is an alternative to traditional dental prosthesis material that is intended exclusively for professional dental work.

SprintRay Digital Temp resin is intended exclusively for professional dental work. Fabrication of dental prosthetics with SprintRay Digital Temp resin requires computer-aided design and CAD/CAM manufacturing system that includes the following components not part of the device: Digital Temp file created in an optical impression system, 3D printer, and curing light equipment.

Digital Temp resin is designed to meet appropriate ISO standards for flexibility and sorption, to withstand prolonged use in the oral cavity. It is delivered nonsterile, and instructions on curing, and cleaning the final device prior to providing it to a patient are provided in the device indication for use document.

The provided text is a 510(k) summary for SprintRay Digital Temp, a light-curable resin used for fabricating temporary dental restorations. It does not contain information on acceptance criteria or studies proving that a device meets such criteria for an AI/ML-based medical device.

Instead, it focuses on the substantial equivalence of the Digital Temp resin to a predicate device based on:

1. Intended Use/Indications for Use: Both are for temporary dental restorations.
2. Technological Characteristics: Both are light-cured acrylate resins used with 3D printers and scanned 3D images.
3. Performance Data: Biocompatibility testing and bench testing based on ISO 10477 were performed, and the resin "functioned as intended."

Therefore, I cannot extract the requested information about acceptance criteria and the study proving an AI/ML device's performance, as the document describes a material (resin) and not an AI/ML algorithm.

The questions you've asked (e.g., sample size for test/training sets, expert ground truth establishment, MRMC studies) are highly relevant to AI/ML device evaluations but are not addressed in this material-focused 510(k) summary.

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• Fabrication of temporary crowns, bridges, inlays, onlays and veneers;
• Fabrication of long-lasting temporary restorations;
• Rebasing of prefabricated temporary crowns made of composite, polycarbonate or metal.

Self-curing composite that is highly efficient for the production of temporary pieces for indirect dental procedures such as inlays, onlays, crowns, veneers and bridges. The product consists of a base paste and a catalyzing paste stored in a cartridge and in a double-body syringe, from where they are automatically dispensed in the correct proportion (1:1), providing practical clinical procedures with reduced chances of errors or incorporated bubbles.

The provided text is a 510(k) summary for the device PrimmaArt, a temporary crown and bridge resin. It describes the device, its indications for use, comparison with a predicate device (Structur 3), and non-clinical testing results.

However, the document does not contain information regarding a study involving human readers, ground truth establishment, sample sizes for test or training sets, or expert qualifications for AI/ML device performance analysis. The acceptance criteria and "device performance" in the context of this document refer to physical and chemical properties of the dental resin, not the performance of an AI/ML algorithm.

Therefore, I cannot provide the requested information for acceptance criteria and study details related to an AI/ML device per the input prompt's structure. The device described, PrimmaArt, is a material, not a software or AI/ML device.

However, I can extract the acceptance criteria and reported device performance for the dental resin based on the provided tables:

1. Table of Acceptance Criteria and Reported Device Performance (for PrimmaArt dental resin):

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

• This information is not applicable as the study involves material testing, not an AI/ML algorithm or dataset. The tests are performed on samples of the PrimmaArt resin. The data provenance is DentsCare LTDA, Brazil, as the manufacturer.

3. 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 device. Ground truth, in this context, refers to the adherence of the material's properties to international standards (e.g., ISO) and internal design inputs.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable as this is not an AI/ML device evaluated by human readers. The assessment is based on direct measurement against established material performance 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 as this is not an AI/ML device.

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

• Not applicable as this is not an AI/ML device. The performance tests are for the material itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the non-clinical testing of the dental resin, the "ground truth" or reference for acceptance is defined by recognized international standards (e.g., ISO 7491, ISO 10477, ISO 4049) and the device's internal design input specifications.

8. The sample size for the training set:

• Not applicable as this is not an AI/ML device. There is no concept of a "training set" for a dental resin material in this context.

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

• Not applicable as this is not an AI/ML device.

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Premium Teeth Resin, when utilized to print 3D printed dental appliances such as denture teeth for complete and partial removable dentures, try-in dentures, provisional full arch implant-supported restoration and provisional restorations such as temporary crowns and bridges, inlays, onlays and veneers, is indicated to replace or restore missing tooth structures or missing teeth.

Formlabs Premium Teeth Resin is a light-curable polymer-based resin of 3D printed dental appliances, such as denture teeth for complete and partial res, try-in dentures, provisional full arch implant-supported restoration, and provisional restorations including temporary crowns and bridges, inlays, onlays and veneers. Formlabs Premium Teeth Resin is used to fabricate patient-specific dental appliances in a stereolithographic (SLA) 3D printer using layer additive manufacturing.

This document is a 510(k) summary for a medical device (Premium Teeth Resin) and does not describe acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML-based medical device.

The provided text focuses on demonstrating substantial equivalence of a new 3D printing resin (Premium Teeth Resin) to a legally marketed predicate device (VarseoSmile Temp) for dental applications. It details the product, its intended use, and compares its technological characteristics and performance to the predicate through non-clinical testing.

Therefore, I cannot extract the information required for your request from this document. The concepts of "acceptance criteria" and "study proving device meets acceptance criteria" as they relate to AI/ML device performance (e.g., sensitivity, specificity, AUC, human reader improvement with AI assistance, ground truth establishment, sample sizes for AI model training/testing) are not present in this regulatory submission for a material.

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Fixtemp® C&B 4:1 is a resin-based material used to fabricate temporary crowns and bridges.

Fixtemp® C&B 4:1 is an automatically mixable self-curing composite, used for the direct and indirect fabrication of temporary crowns and bridges. Fixtemp C&B 4:1 is a Type 1 – polymer-based material, per ISO 10477:2020. It is available in the tooth colors A1, A2, A3, A3.5, B1 and Bleach X.

1. A table of acceptance criteria and the reported device performance

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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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PMMA BLOCK is used for the fabrication removable or temporary dental structures, such as crowns and bridges using milling technology using CAD/CAM.

Indications for Use:

• Temporary anterior and posterior crowns;
• Temporary anterior and posterior bridges;
• Removable structures for dentures;
• Removable structures for therapeutic restorations (night guards, bite splints or occlusal splints).

PMMA BLOCK is a circular solid (disc) or rectangular solid (block) of PMMA with or without post attachment for use in a CAD/CAM milling machine for production of provisional restorative prostheses such as dental crowns and bridges and removable dental structures. These blocks are available in a variety of shapes for different milling systems and are also available in variety of dental shades.

The provided text is a 510(k) Summary for a medical device called "PMMA BLOCK." This document describes the device, its intended use, and compares it to a predicate device to demonstrate substantial equivalence, primarily focusing on physical and chemical properties and biocompatibility.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. A table of acceptance criteria and the reported device performance:

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