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Aquasil® Ultra + Smart Wetting® Impression Material is indicated for all dental impression techniques.

Aquasil® Ultra+ Smart Wetting® Impression Material is a quadrafunctional hydrophilic addition reaction silicone elastomeric dental impression material with excellent hydrophilic properties, dimensional accuracy, high tear strength, and resistance to permanent deformation.

This document describes the Aquasil® Ultra+ Smart Wetting® Impression Material, a dental impression material. The submission focuses on demonstrating substantial equivalence to a predicate device after a modification to the surfactant used in the material.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is a series of non-clinical bench tests and biocompatibility tests. The document states:

• "The performance of the Aquasil® Ultra + Smart Wetting® Impression Material satisfactorily met the requirements of the non-clinical bench testing conducted to support substantial equivalence."
• "The results of the biocompatibility testing of Aquasil® Ultra + Smart Wetting® Impression Material are equivalent to the predicate device Aquasil® Ultra Smart Wetting® Impression Material 510(k) cleared under K113406."
• "The test results of Aquasil Ultra + Smart Wetting® Impression Material LV Base and Catalyst paste, met the requirements of the three recommended biocompatibility tests; as per ISO10993-1:2009; Cytotoxicity, Sensitization (Delayed-type hypersensitivity), and Irritation or intracutaneous reactivity."
• "Other tests, including Contact Angle and Tear Strength were performed and the results of these activities... support substantial equivalence."

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

• Sample Size: The document does not specify the exact sample sizes used for each individual test. It mentions that "All required verification and validation activities, as identified through risk analysis were performed."
• Data Provenance: The data provenance is primarily from bench testing and biocompatibility studies conducted by DENTSPLY International, Inc. This would typically be prospective testing performed in a controlled laboratory environment to evaluate the modified device. There is no mention of country of origin for the data beyond DENTSPLY's location in York, PA, USA.

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

• This information is not provided in the document. The testing described is primarily physical property measurement and biocompatibility studies, which do not typically involve human expert interpretation of results to establish ground truth in the way medical imaging algorithms do. The "ground truth" here is objective measurement against established ISO standards and internal procedure requirements.

4. Adjudication Method for the Test Set

• Adjudication methods (e.g., 2+1, 3+1) are typically relevant for human-interpreted data, especially in clinical trials or image-based diagnostic studies. Since this submission is for a dental impression material and focuses on non-clinical performance and biocompatibility, an adjudication method for a test set is not applicable and therefore not described.

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

• No MRMC comparative effectiveness study was done. This is a submission for a dental impression material, not an AI-powered diagnostic device, so this type of study is not applicable.

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

• This is not an AI-powered device. Therefore, a standalone algorithm performance evaluation is not applicable. The tests are performed on the material itself.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• The "ground truth" for the non-clinical performance tests and biocompatibility studies is based on established international standards (ISO, OECD) and internal DENTSPLY procedure requirements. This is an objective, quantitative ground truth.

8. The Sample Size for the Training Set

• This is not an AI/machine learning device that requires a training set. Therefore, sample size for a training set is not applicable.

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

• As this is not an AI/machine learning device, there is no training set and therefore no ground truth established for a training set.

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AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL is indicated for all dental impression techniques.

AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL is a two-part catalyst/base hydrophilic viny!polysiloxane elastomeric impression material suitable for all dental impression techniques where a light body (wash) and/or medium/heavy body (tray) material would be desired by the operator. Aquasil Ultra Smart Wetting Impression Material is available in light-bodied, medium-bodied or heavy-bodied consistencies; and fast set. regular set or extended work time.

This document describes a 510(k) premarket notification for AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL. This submission is for modifications to already cleared products, not for a new device requiring a full de novo clearance or extensive new clinical data. Therefore, the information provided focuses on the substantial equivalence to existing devices rather than new performance data against specific acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The submission explicitly states: "There are no changes affecting the fundamental technology and chemical composition of the subject materials. There are minor quantitative changes to the existing ingredients in the material composition, but these changes do not affect the physical characteristics and mechanical properties of the materials."

Therefore, explicit new acceptance criteria and new reported performance are not provided in this document. The device relies on the performance data established for its predicate devices.

2. Sample Size for the Test Set and Data Provenance

No new test set data is provided or referenced, as the submission focuses on documenting minor changes to an already cleared device and asserting substantial equivalence based on the lack of impact on fundamental technological characteristics, physical properties, or mechanical properties. Therefore, this information is not applicable to this submission.

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

Not applicable. No new test set requiring expert ground truth establishment was conducted or referenced.

4. Adjudication Method for the Test Set

Not applicable. No new test set requiring adjudication was conducted or referenced.

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

No. This submission does not involve a multi-reader multi-case comparative effectiveness study. The device is a dental impression material, not an imaging or diagnostic device typically subject to MRMC studies.

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

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

7. The Type of Ground Truth Used

Not applicable. As no new performance testing showing specific new results against a ground truth was conducted for this 510(k) to demonstrate new performance, this information is not relevant. The substantial equivalence relies on the unchanged fundamental characteristics and previously established performance of the predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is a manufactured dental material; there is no "training set" in the context of an algorithm or AI.

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

Not applicable. There is no training set.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is not a new clinical or performance study. Instead, the submission relies on demonstrating substantial equivalence to existing, legally marketed predicate devices. The "study" in this context refers to the analysis and documentation provided by the manufacturer (DENTSPLY International) to the FDA, asserting that:

• Technological Characteristics: No changes affect the fundamental technological characteristics of the device.
• Material Composition: The components have all been used in the predicate devices. While there are "minor quantitative changes to the existing ingredients," these changes "do not affect the physical characteristics and mechanical properties of the materials."
• Non-Clinical Performance Data (Toxicological Testing): All components have been previously used in cleared devices, and there are no changes to the material composition from a toxicological perspective. This implies that the toxicological profile remains consistent with the already cleared devices.
• Physical Properties & Mechanical Properties: The minor quantitative changes do not affect these properties. Therefore, the device is presumed to perform identically to its predicates in terms of physical and mechanical behavior relevant to dental impressions.
• Clinical Performance Data: Stated as "Not applicable," further reinforcing that no new clinical studies were conducted for this specific 510(k) submission.

In essence, the "proof" is the argument of no significant change from the predicate devices that would alter safety or effectiveness, thus maintaining the established acceptance criteria of those predicates. The FDA concurred with this assessment, issuing a substantial equivalence determination.

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