(142 days)
Cavex Cream Alginate is an irreversible hydrocolloid dental impression material used by the dentist for taking impressions of the oral cavity with the purpose of constructing a gypsum cast that is a copy of the situation in the mouth. It is a general purpose impression materials for making study models, first impressions for the construction of individual trays, situation models, orthodontic impressions.
Cavex Cream Alginate impression material is an impression material with a creamy consistency for general dental practice and for orthodontics. It is presented in the form of a purple colored powder with bubble gum flavor.
This document is a 510(k) summary for the Cavex Cream Alginate impression material. It demonstrates substantial equivalence to existing predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance for Cavex Cream Alginate
| Physical Parameters | Acceptance Criteria (ADA 18 Requirements) | Reported Device Performance (Cavex Cream Alginate - K151535) |
|---|---|---|
| Appearance | N/A | Powder |
| Color | N/A | Purple |
| Flavor | N/A | bubble-gum |
| Compatibility & Detail Reproduction | 0 - 50 µm | Complies |
| Recovery from Deformation | >95 % | 96 % |
| Strain in Compression | 5 - 20 % | 16 % |
| Compressive Strength | > 0.35 MPa | > 0.80 MPa |
| Deterioration (This likely refers to tear strength or similar, but is labeled as "Deterioration" in the table) | > 0.294 MPa | > 0.60 MPa |
Note: The FDA 510(k) summary explicitly states that the device was deemed "substantially equivalent" based on this performance data and comparison to predicate devices, thus demonstrating it meets the necessary criteria for market entry.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the performance testing of the Cavex Cream Alginate or its predicate devices.
The data provenance is also not explicitly stated as country of origin or whether it's retrospective or prospective. However, given that the submitter is "Cavex Holland BV" located in Haarlem, The Netherlands, it's highly probable the testing was conducted in The Netherlands or by a laboratory collaborating with a Dutch company. The testing seems to be laboratory-based physical performance testing rather than clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This document describes performance testing of material properties, not clinical diagnostic accuracy. Therefore, there were no experts used to establish "ground truth" in the context of clinical interpretation, as would be the case for an AI-powered diagnostic device. The "ground truth" for the material properties would be established by standardized laboratory testing procedures and reference standards (e.g., ADA Specification No. 18).
4. Adjudication Method for the Test Set
Not applicable. This is not a clinical study requiring adjudication of expert interpretations. The performance data is derived from objective physical property measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This document pertains to traditional dental impression material, not an AI-powered device, and therefore no MRMC study was conducted or is relevant.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is a physical medical device (impression material), not an algorithm or AI-powered device.
7. Type of Ground Truth Used
The ground truth used for performance assessment are the established physical property requirements for alginate impression materials, specifically those outlined in ADA (American Dental Association) Specification No. 18. This specification provides objective, measurable criteria for various properties like detail reproduction, recovery from deformation, strain in compression, compressive strength, and tear strength (likely referred to as "deterioration" here). The reported values are compared directly against these quantitative benchmarks.
8. Sample Size for the Training Set
Not applicable. This document describes a physical medical device that does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this type of device.
§ 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).