(6 days)
- Two step putty/wash impression technique
- One step putty/wash impression technique
- Two step putty/wash impression technique using a foil (plastic putty spacer)
- One step putty impression technique for forming functional peripheries
Vonflex™ Putty, as the additional polymerization silicone type, is a rubber impression material that makes oral tissue shape precisely. And it is very easy to handle and has low shrinkage, helping to make precise impression taking.
This 510(k) summary describes a dental impression material, Vonflex™ Putty, and its substantial equivalence to a predicate device, Panasil Putty Soft. The document focuses on demonstrating that the new device has similar characteristics and performs as safely and effectively as the existing one.
Here's an analysis of the provided text in relation to the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantifiable manner (e.g., specific thresholds for flow properties, setting time). Instead, it uses qualitative statements to claim similarity to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance (Claim) |
|---|---|
| Use concept | Vonflex™ Putty has similar characteristics as the predicate device regarding "Use concept." |
| Flow properties | Vonflex™ Putty has similar characteristics as the predicate device regarding "Flow properties." |
| Setting time | Vonflex™ Putty has similar characteristics as the predicate device regarding "Setting time." |
| Compatibility with die/cast | Vonflex™ Putty has similar characteristics as the predicate device regarding "Compatibility with the die and cast materials." |
| Biocompatibility | Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for any testing. It states that "Vonflex™ Putty has been subjected to extensive safety, performance, and product validations prior to release" and that "Safety tests including biocompatibility have been performed."
The manufacturer, Vericom Co., Ltd., is located in the Republic of Korea. Therefore, the data provenance is likely Republic of Korea, and given the context of product validation prior to release, the studies would be prospective in nature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The submission relies on comparative claims with a predicate device and mentions "safety, performance, and product validations," but does not detail the methodology or expert involvement for establishing ground truth for any specific test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for a dental impression material, not an AI-based device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone (algorithm only) performance study was not done. This submission is for a physical dental impression material, not a software algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document primarily relies on physical and chemical property comparisons to a predicate device. The "ground truth" for a dental impression material would be its ability to accurately replicate oral tissue shape, its stability, and its biocompatibility. While expert assessment is implicitly part of "product validations," the specific type of ground truth (e.g., measured accuracy against known standards, expert evaluation of impression quality) is not detailed. Biocompatibility would rely on standard in-vitro and potentially in-vivo tests, with "ground truth" established by compliance with international regulations.
8. The sample size for the training set
This information is not applicable as this is not an AI/machine learning device that would require a "training set."
9. How the ground truth for the training set was established
This information is not applicable for the same reason as above.
§ 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).