Vonflex S
FDA 510(k) K152615 · Vericom Co., Ltd.
510(k) numberK152615
Submission
- Device name
- Vonflex S
- Applicant
- Vericom Co., Ltd.
Chuncheon-Si, KR - Received
- September 14, 2015
- Decision date
- November 3, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K203672 | MAZIC Claro CAD and MAZIC Claro PressEIH · Traditional | 07/01/2021SE |
| K193260 | U-Cem Premium & MAZIC CemEMA · Traditional | 08/21/2020SE |
| K170950 | Well-Root STKIF · Traditional | 12/20/2017SE |
| K163346 | MAZIC DuroEBF · Traditional | 03/17/2017SE |
| K160377 | V-varnish PremiumLBH · Traditional | 12/02/2016SE |
| K152518 | Vonflex S PuttyELW · Traditional | 11/30/2015SE |
| K140966 | Vonflex S BiteELW · Traditional | 08/15/2014SE |
| K103164 | Vonflex Heavy, Vinflex LightELW · Traditional | 11/10/2010SE |
Questions and answers
When was Vonflex S cleared by the FDA?
Vonflex S (K152615) received a 510(k) decision of Substantially Equivalent on November 3, 2016, 416 days after the submission was received.
What is the product code of K152615?
The FDA product code is ELW – Material, Impression, a Class II (moderate risk) device regulated under 21 CFR 872.3660.