(90 days)
DentiAnn Light-body is to be used as a light body material for:
- Two step putty/wash technique
- · Single step putty/wash technique
- Functional peripheries
- Reline impressions
- = Crown/bridge work
- Inlays, Onlays
DentiAnn Heavy-body is to be used as a heavy body material for:
- · Two step putty/wash technique
- · Single step putty/wash technique
- · Functional peripheries
- Crown/bridge work
- Inlays, Onlays
SmartSil-Putty is to be used as a preliminary material for:
- · Two step putty/wash technique
- · Single step putty/wash technique
- · Functional peripheries
- Crown/bridge work
- · Inlays, Onlays
SmartSil-Bite is to be used as a light body material for:
- = Making accurate occlusal registrations
- Standards bite registrations in the end bite position.
- · Key material for needle point registration.
- · Production of small model segments
DentiAnn Smart Sil is a two component (base paste and catalyst, mixing ratio 1:1) vinyl polysiloxane impression material to be used for impressions, where typically alginates are used. The DentiAnn Smart Sil offers four different viscosities (light, heavy, putty and bite) in delivery systems of cartridges, tubes and/or jars. The device includes accessories such as a mixing tip and a spoon.
The DentiAnn Smart Sil is a dental impression material. The acceptance criteria for the device are based on the ISO 4823 standard for dental elastomeric impression materials. The study used to prove the device meets these criteria involved non-clinical performance testing.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (ISO 4823 Standard) | DentiAnn Smart Sil Reported Performance |
|---|---|
| DentiAnn Light-body | |
| Working time | ~180 sec |
| Elastic recovery rate | > 96.5% |
| Linear Dimensional change | 96.5% |
| Linear Dimensional change | 96.5% |
| Linear Dimensional change | 20HD |
| General Criteria | |
| Component Color Test | Met (implied by overall compliance) |
| Consistency Test | Met (implied by overall compliance) |
| Mixing Time Test | Met (implied by overall compliance) |
| Detail Reproduction Test | Met (implied by overall compliance) |
| Test for Compatibility with Gypsum | Met (implied by overall compliance) |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for each specific test within ISO 4823. It refers to "the test results" generally. The data provenance is non-clinical, meaning it's from laboratory testing rather than human subjects. The origin of the data is from the manufacturer, SeilGlobal Co., Ltd., which is based in the Republic of Korea. The data is prospective as it was generated to support the 510(k) submission for this specific device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. This is a non-clinical study pertaining to the physical and mechanical properties of a material. Ground truth in this context refers to the defined parameters and methods within the ISO 4823 standard, not expert consensus on medical images or diagnoses.
4. Adjudication Method for the Test Set:
Not applicable. Performance was measured against objective standards of ISO 4823 using laboratory equipment, not through expert adjudication.
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 device is a dental impression material, not an AI-powered diagnostic or assistive tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is a material, not an algorithm.
7. The Type of Ground Truth Used:
The ground truth for the performance testing was based on:
- International Standard ISO 4823: This standard specifies the requirements and test methods for dental elastomeric impression materials.
- International Standard ISO 10993 (Biocompatibility): This set of standards concerns the biological evaluation of medical devices.
8. The Sample Size for the Training Set:
Not applicable. This is a material, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. This device does not use a training set.
§ 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).