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DENU Light Body(Regular, Fast) / DENU Heavy Body(Regular, Fast)

• Crown and bridge impression
• Inlay and onlay impression
• Denture impression
• Model impression

DENU Putty Set(Regular, Fast)

• Crown and bridge impression
• Inlay and onlay impression

The DENU family of silicone impression materials consists of three different viscosities (light body, heavy body, putty) for various application systems. Products are further classified into Regular type and Fast type, depending on curing time, but there is no difference on viscosity, indications for use, or scope of use. Each device is consisted of 1:1 base and catalyst component, packaged in 560mL jars for DENU Putty set and 50mL syringes for other devices.

This is a 510(k) premarket notification for a dental impression material, DENU Light Body (Regular, Fast), DENU Heavy Body (Regular, Fast), and DENU Putty Set (Regular, Fast). The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and supporting study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from the international standard ISO 4823:2021 (Dentistry - Elastomeric impression materials) and the device's performance is compared to these standards and the predicate devices.

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

The document does not explicitly state the sample sizes for each specific physical property test (e.g., how many samples were tested for working time, consistency, etc.). The testing was based on ISO 4823:2021 and other biocompatibility standards (ISO 7405, ISO 10993-10, ISO 10993-11). These standards typically specify the number of samples required for each test. Given the context of a 510(k) submission, it is assumed that the protocol for each standard was followed, including the specified sample sizes (though not explicitly listed in this summary).

The data provenance is retrospective, as the tests have already been performed and the results are being presented. The manufacturer, HDI, Inc., is based in South Korea, implying the tests were likely conducted there or by affiliated labs.

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

This submission describes physical and biological bench testing of an impression material against established international standards. There is no mention of human expert involvement or a "ground truth" established by experts in the context of diagnostic interpretation for this type of device. The "ground truth" for these tests is the objective measurement of physical and chemical properties as defined by the ISO standards.

4. Adjudication method for the test set

Not applicable. As described in point 3, this is bench testing of physical and biological properties. There is no expert adjudication process in this context.

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 submission for a dental impression material, not an AI-powered diagnostic device. No MRMC study was performed.

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

Not applicable. This is a dental impression material, not an algorithm or AI.

7. The type of ground truth used

The ground truth used for this device's evaluation is primarily objective physical and chemical measurements as defined by:

• International Standards: Specifically, ISO 4823:2021 (Dentistry - Elastomeric impression materials) and ISO 10993 series (Biological evaluation of medical devices).
• Predicate Device Performance: The performance characteristics of the proposed device are directly compared to those of the predicate devices (Vonflex STM and Vonflex S Putty).

8. The sample size for the training set

Not applicable. There is no AI or machine learning component to this device, so there is no training set in the conventional sense. The "training" for the device's performance could be considered the iterative formulation and testing by the manufacturer to meet the required specifications, but this is not a data-driven training set like in AI.

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

Not applicable. As there is no training set for an AI/ML algorithm, this question does not apply.

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DENU Composite Resin is indications for use in:

• Direct anterior and posterior restorations
• Core buildup
• Splinting
• Indirect anterior and posterior restorations including inlays, onlays and veneers

DENU Flow Resin is indications for use in:

• Class III restorations
• Class V restorations
• Small Class I restorations (non stress-bearing restorations)
• Pit and fissure sealing in molars and premolars
• Repair of small defects in esthetic indirect inlays
• Base/liner under direct restorations

DENU Composite Resin is light-cured composite resin which can be used in anterior and posterior teeth. This is classified into type 1, class 2, group 1 according to 4, ISO 4049:2019.

DENU Flow Resin is light-cured flowable composite resin which can be used in anterior and posterior teeth. This is classified into type 1, class 2 group 1 according to 4, ISO 4049:2019.

Please note: The provided document is a 510(k) summary for a dental resin material, not an AI/ML medical device. Therefore, many of the requested elements for describing AI/ML device studies (e.g., sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies) are not applicable to this type of traditional medical device submission.

I will address the applicable acceptance criteria and study information as presented in the document for the DENU Composite Resin and DENU Flow Resin.

Here's the information extracted from the provided text regarding the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents performance data for two devices: DENU Composite Resin and DENU Flow Resin, comparing them against predicate devices and indicating whether they meet acceptance criteria. The acceptance criteria are implicitly derived from the predicate device values and the referenced ISO standards (ISO 4049 and ISO 10993 series). The document states that "All the test results met the preset test criteria."

DENU Composite Resin

DENU Flow Resin

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

The document does not specify the exact sample sizes (number of specimens) used for each physical property test. It mentions that "The following test articles were tested based on the referenced standard," which refers to ISO 4049 and ISO 10993. These standards typically specify the number of specimens required for each test. The data provenance is laboratory testing of the device itself, not clinical data from a specific country or retrospective/prospective studies.

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

Not applicable. This is a material science study involving physical and chemical property testing, not an AI/ML device relying on expert consensus for ground truth. The "ground truth" is established by direct measurement of the material properties described in the ISO standards.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers or experts, which is not relevant to laboratory-based material property testing.

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 material, not an AI/ML device, so no MRMC study was performed.

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

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

7. The type of ground truth used

The ground truth for the performance testing is based on standardized laboratory measurements of physical and biological properties, as defined by the referenced ISO standards (ISO 4049 for physical properties, ISO 10993 for biocompatibility). These are objective, quantitative measurements rather than expert consensus, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set

Not applicable. This is a traditional medical device (dental resin), not an AI/ML device that requires a training set. The device formulation and manufacturing process would be optimized through R&D, but not in the context of a "training set" for an algorithm.

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

Not applicable. As there is no training set as understood in AI/ML, there is no ground truth established for it.

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