(279 days)
The Sildent is a vinyl polysiloxane silicone impression material used for all inlay, crown and bridge, edentulous and partial impressions.
The Sildent is a vinyl polysiloxane silicone impression material used for all inlay, crown and bridge, edentulous and partial impressions.
The Sildent consists of 4 type models. These are Sildent light body, Sildent regular body, Sildent heavy body and Sildent putty.
This describes the acceptance criteria and study proving the device meets those criteria for the Sildent dental impression material.
1. Table of Acceptance Criteria and Reported Device Performance
The submission highlights bench testing against ISO 4823 for various performance characteristics. The acceptance criteria are implicitly that the Sildent device performs comparably to the predicate devices and meets the requirements of ISO 4823.
| Performance Characteristic | Acceptance Criteria (Implicit from Predicate & ISO 4823) | Reported Sildent Performance |
|---|---|---|
| Biocompatibility | No toxicity, sensitization, or irritation | Demonstrated safe for use |
| Dimensional Change | Comparable to predicate and within ISO 4823 | Demonstrated in testing |
| Elastic Recovery | Comparable to predicate and within ISO 4823 | Demonstrated in testing |
| Strain-in Compression | Comparable to predicate and within ISO 4823 | Demonstrated in testing |
| Working Time | Comparable to predicate and within ISO 4823 | Demonstrated in testing |
| Consistency | Comparable to predicate and within ISO 4823 | Demonstrated in testing |
| Mixing Time | Comparable to predicate and within ISO 4823 | Demonstrated in testing |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes for each of the bench tests (e.g., how many samples were tested for dimensional change). The data provenance is Korea, Republic of, as HRS CO., LTD. is located there. The studies were non-clinical bench tests. The document does not explicitly state if the studies were retrospective or prospective, but bench testing on a new product prior to market release is inherently prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This was a non-clinical bench study, not involving human interpretation or expert ground truth as typically understood in AI/medical imaging studies. The "ground truth" was established by the physical and chemical properties measured according to ISO 4823 and comparison to predicate devices.
4. Adjudication Method for the Test Set
Not applicable. There was no human adjudication process involved in these bench tests.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No. This was a non-clinical bench study for a dental impression material. MRMC studies are typically for diagnostic devices that involve human interpretation of medical images.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Yes, in a sense. The bench tests evaluated the material's inherent physical and chemical properties in a standalone manner, without human intervention or interpretation of results in the way an algorithm's performance might be evaluated. The "algorithm" here is the material itself.
7. Type of Ground Truth Used
The ground truth for the performance characteristics was derived from established scientific measurement standards (ISO 4823) and comparison to the characteristics of legally marketed predicate devices. For biocompatibility, the ground truth was based on the results of standard biocompatibility tests (Cytotoxicity, Sensitization, Short term systemic toxicity, Oral mucosa irritation, Diffusion Test).
8. Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for this 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).