(87 days)
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.
| Acceptance Criteria Category | Original Performance (from Predicate Devices) |
|---|---|
| Toxicological Safety | Components previously cleared and used in predicate devices; no changes to material composition. Implies existing toxicological safety is maintained. |
| Physical Characteristics | No changes affecting fundamental technology or chemical composition. Minor quantitative changes to existing ingredients do not affect physical characteristics and mechanical properties. Implies existing physical characteristics (e.g., set time, consistency, hydrophilicity, tear strength, dimensional stability relevant to impressions) are maintained. |
| Mechanical Properties | No changes affecting fundamental technology or chemical composition. Minor quantitative changes to existing ingredients do not affect physical characteristics and mechanical properties. Implies existing mechanical properties (e.g., hardness, elasticity, detail reproduction) are maintained. |
| Indications for Use | Original broad indications for "all dental impression techniques" maintained, with some consolidation/clarification in this submission. |
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.
§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).