(62 days)
Aquasil™ XLV Smart Wetting Impression Material is used as an impression material in a dual phase impression technique. It may also be used for precise duplication of models.
Regular Set is used for capturing multiple unit impressions. It is suitable for all impression techniques where the operator needs an extra low viscosity material.
Fast Set is used for capturing one preparation only (single unit crown); ideal for double arch dual phase techniques.
AQUASIL™ XLV SMART WETTING IMPRESSION MATERIAL is an extra low viscosity. elastomeric impression material with excellent hydrophilic properties, dimensional accuracy. high tear strength, and resistance to permanent deformation. AQUASIL XLV IMPRESSION MATERIAL with "smart wetting" improves wetting both the tooth surface and the model detail reproduction.
AQUASIL XLV SMART WETTING IMPRESSION MATERIAL is available in Regular Set and Fast Set. It is available in cartridge delivery. In developing the Regular Set and Fast Set, adjustments were made to the active ingredients as compared to the predicate device (K943574). These adjustments were made to obtain two speeds of the material with improved physical properties. The speed of the materials was adjusted by increasing the amounts of catalyst and retarder fluids over the predicate device. These changes improved the setting properties of the mixed impression material and allowed for two speeds of the same viscosity of impression material. Other changes were made to improve the flow property of the mixed impression material and the shelf stability of the product.
AQUASIL™ XLV SMART WETTING IMPRESSION MATERIAL is a twopart (base/catalyst) hydrophilic viny|polysiloxane (VPS), impression material used to record the details of hard and soft surfaces of the oral cavity.
This 510(k) submission for the AQUASIL™ XLV SMART WETTING® IMPRESSION MATERIAL does not contain information about acceptance criteria or a study that directly proves the device meets specific performance metrics in comparison to a predicate device, as one would typically expect for a medical device.
Instead, the submission focuses heavily on substantial equivalence to the predicate device (Aquasil™ Smart Wetting Impression Material, K943574) based on:
- Similarity of formulation: All components of the new device have been used in legally marketed DENTSPLY devices.
- Minor adjustments leading to improved physical properties: "adjustments were made to the active ingredients as compared to the predicate device (K943574). These adjustments were made to obtain two speeds of the material with improved physical properties. The speed of the materials was adjusted by increasing the amounts of catalyst and retarder fluids over the predicate device. These changes improved the setting properties of the mixed impression material and allowed for two speeds of the same viscosity of impression material. Other changes were made to improve the flow property of the mixed impression material and the shelf stability of the product."
- Prior biocompatibility testing of the predicate device: The submission states, "Due to the similarity of the formulation of AQUASIL XLV SMART WETTING IMPRESSION MATERIAL to the predicate device (K943574), we believe that additional biocompatibility testing of the new impression material is unnecessary." It then refers to biocompatibility test results for the predicate device (K943574), which found it to be non-mutagenic, non-toxic, and a non-irritant.
- Limited exposure time in the mouth (less than ten minutes).
Therefore, I cannot provide the requested table or describe a 'study that proves the device meets the acceptance criteria' in the traditional sense of performance metrics against specific acceptance thresholds for this specific device. The "performance data" referred to is primarily the biocompatibility of the predicate device, which is inferred to apply to the new device due to formulation similarity, and general statements about improved physical properties.
Here's what information can be extracted/inferred based on the provided text, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
No explicit acceptance criteria for performance (e.g., detail reproduction, dimensional accuracy) are stated for the AQUASIL™ XLV SMART WETTING® IMPRESSION MATERIAL in this document. The performance information provided is related to biocompatibility, inferred from the predicate device.
| Performance Metric (Biocompatibility - inferred from predicate) | Acceptance Criteria (inferred from predicate testing) | Reported Device Performance (for predicate, applied to new device) |
|---|---|---|
| Cytotoxicity | Acceptable level of cytotoxicity | Base pastes: Moderate cytotoxicity. Catalyst pastes: Non-cytotoxic. Mixed product: Cytotoxicity persisted, but lower than Reprosil® Impression Material. |
| Mutagenicity (Ames Test) | Non-mutagenic | Non-mutagenic |
| Acute Dermal Toxicity | Non-toxic | Non-toxic |
| Irritation (Hamster Cheek Pouch Study) | Non-irritant | Non-irritant |
| Detail Reproduction, Dimensional Stability, Tear Strength | Not explicitly stated in this document | Device described as having "excellent hydrophilic properties, dimensional accuracy, high tear strength, and resistance to permanent deformation." However, no specific quantitative values or acceptance criteria are given, nor is a study comparing these to the predicate's performance. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified for any performance testing of the AQUASIL™ XLV XLV SMART WETTING IMPRESSION MATERIAL. The biocompatibility tests referenced are for the predicate device, and their sample sizes are not provided in this document.
- Data Provenance: The biocompatibility tests were likely conducted by DENTSPLY or a contracted lab. The country of origin of the data is not specified. The tests are retrospective in relation to this 510(k) submission, as they were conducted on the predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable. This document describes a 510(k) submission based on substantial equivalence and biocompatibility testing (of a predicate), not a study involving experts to establish ground truth for performance metrics.
4. Adjudication Method for the Test Set
- Not applicable. No adjudication method is mentioned as there's no clinical study or expert review panel described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done (or at least not reported in this document). The device is an impression material, not an imaging or diagnostic device that would typically involve human readers.
6. Standalone (Algorithm Only) Performance Study
- Not applicable. This device is a physical impression material, not an algorithm or software.
7. Type of Ground Truth Used
- For biocompatibility: Laboratory test results (e.g., cell culture for cytotoxicity, animal models for toxicity/irritation) serve as the "ground truth" for assessing biological safety. This is based on established scientific protocols.
- For physical properties (e.g., dimensional accuracy, tear strength, flow): While the device is described as having these improved properties, no specific studies or quantitative ground truth measurements are provided in this document to support these claims for the XLV version compared to its predicate. The "improvements" are mentioned as being achieved through "adjustments... to obtain two speeds of the material with improved physical properties."
8. Sample Size for the Training Set
- Not applicable. There is no "training set" as this is not a machine learning or AI device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. (See point 8).
§ 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).