(88 days)
It is used for all crown, bridge and orthodontic impression techniques.
Vonflex S™ Putty, as the additional polymerization silicone type, is composed of vinyl polysiloxane impression materials that make oral tissue shape precisely. polychoxane improofien materials that natio of a looks probobility, helps to make precise impression taking.
This is a 510(k) premarket notification for a dental impression material, Vonflex S™ Putty, and not an AI or software device. Therefore, many of the requested categories related to AI/software performance, such as sample sizes for test/training sets, ground truth establishment for AI, MRMC studies, and AI-specific acceptance criteria, are not applicable to this document.
The acceptance criteria and performance data presented here are for the physical and biological properties of a dental material.
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (ISO 4823) | Reported Device Performance (Vonflex S™ Putty) |
|---|---|
| Physical Properties: | |
| Classification according to ISO4823 | Type 0 |
| Dimensional accuracy: Max. 1.5% | Max. 1.5% |
| Consistency: Max. 35mm | Max. 35mm |
| Compatibility with the die and cast materials: 75μm reproduction | 75μm reproduction |
| Curve of the shrinkage (Strain in compression): Min. 0.8% ~ Max. 20% | Min. 0.8% ~ Max. 20% |
| Biocompatibility Tests (ISO 10993): | |
| Cytotoxicity (ISO 10993-5) | Passed (Biocompatible for intended use) |
| Sensitization and Irritation (ISO 10993-10) | Passed (Biocompatible for intended use) |
| In vitro genotoxicity (Ames test) (ISO 10993-3) | Passed (Biocompatible for intended use) |
2. Sample sized used for the test set and the data provenance:
This document describes performance testing for a dental impression material. The specific sample sizes for each physical property test are not detailed in this summary. The data provenance is Vericom Co., Ltd., Republic of Korea, as they conducted the tests (prospective in the context of this submission).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is for performance testing of a physical material, not for a diagnostic device requiring expert interpretation or ground truth establishment in the typical AI/software sense. The "ground truth" for these tests are the defined standards within ISO 4823 and ISO 10993.
4. Adjudication method for the test set:
Not applicable. This is for performance testing of a physical material, not for a diagnostic device with human interpretation.
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:
Not applicable. This is not an AI-powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI-powered device.
7. The type of ground truth used:
For physical properties, the "ground truth" is defined by the requirements and test methods specified in the international standard ISO 4823 (Dentistry - Elastomeric impression materials). For biocompatibility, the "ground truth" is based on the safety endpoints and test methods specified in ISO 10993 (Biological evaluation of medical devices).
8. The sample size for the training set:
Not applicable. This is not an AI-powered device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI-powered device that requires a training set or its associated ground truth establishment.
§ 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).