(61 days)
The Dental Impression Material is intended for use with all crowns, bridges, and orthodontic impression techniques to reproduce the structure of a patient's teeth and gums.
The Dental Impression Material is a kind of addition-cure rubber impression material composed of vinyl polysiloxane and various fillers, with neutral smell and applicable to impression in dentistry.
The Dental Impression Material is very easy to mix and has good dimensional stability which helps to make precise impression taking.
The information provided describes the acceptance criteria and performance of the Dental Impression Material by Chemoment Materials Co.,ltd, as detailed in the 510(k) summary K221668.
Here's a breakdown of the requested information:
1. Table of acceptance criteria and the reported device performance
| Item | Proposed device | Acceptance criteria (Type 0) | Result |
|---|---|---|---|
| Consistency | 31.8mm | ≤35mm | Pass |
| Compatibility with gypsum | Complied | 75μm | Pass |
| Detail reproduction | Complied | 75μm | Pass |
| Linear dimensional change | 0.798% | ≤1.5% | Pass |
| Elastic recovery | 97.718% | ≥96.5% | Pass |
| Strain in compression | 5.44% | 0.8~20% | Pass |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample size for each performance test. It states that "Non-clinical tests were conducted to verify that the proposed device met all design specifications as same or similar to the predicate device." These tests were conducted according to ISO standards (ISO 10993-05, ISO 10993-10, and ISO 4823:2021). The data provenance is not explicitly mentioned but is implied to be from laboratory testing performed by or for Chemoment Materials Co.,ltd as part of their regulatory submission. The tests are non-clinical, meaning they don't involve human subjects, and are therefore not classified as retrospective or prospective human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The device's performance was evaluated against established engineering and material science standards (ISO standards), not against a ground truth established by medical experts for diagnostic purposes.
4. Adjudication method for the test set
This information is not applicable as the tests are objective measurements against established standards, not subjective assessments requiring 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
No such study was conducted. This device is a material (dental impression material), not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a material, not an algorithm.
7. The type of ground truth used
The "ground truth" for the device's performance is defined by the objective pass/fail criteria set forth in the international standards ISO 4823:2021, and the biocompatibility standards ISO 10993-05:2009 and ISO 10993-10:2010. These standards provide specific measurable parameters for acceptable performance for dental impression materials.
8. The sample size for the training set
This is not applicable. The product is a material, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable as 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).