Identifiers
- 510(k) Number
- K152518 FDA 510(k)
- FDA Product Code
- ELW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3660 FDA 510(k)
- Regulation Number
- 872.3660 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Vonflex S Putty is a dental material and impression device. It is classified as a class 2 device. The device is used in dental applications.
The Vonflex S Putty is supplied with a product code of ELW and a regulation number of 872.3660. It has been authorized with an FDA 510K clearance. The device is intended for use in a dental setting.
Frequently asked questions
What is the Vonflex S Putty used for?
The Vonflex S Putty is used in dental applications as a dental material and impression device.
What is the regulatory classification of the Vonflex S Putty?
The Vonflex S Putty is classified as a class 2 device with an FDA 510K clearance.
What product code is associated with the Vonflex S Putty?
The Vonflex S Putty has a product code of ELW and a regulation number of 872.3660.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K152518 | Class II | Active |
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Manufacturer
- Manufacturer
- Vericom Co., Ltd.
Sources (1)
- FDA 510(k) K152518 24 fields · synced Sep 23, 2026