Vonflex S Bite
FDA 510(k) K140966 · Vericom Co., Ltd.
510(k) numberK140966
Submission
- Device name
- Vonflex S Bite
- Applicant
- Vericom Co., Ltd.
Chuncheon-Si, Gangwon - Do, KR - Received
- April 15, 2014
- Decision date
- August 15, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code ELW
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|---|---|---|---|
| K254112 | Dia-X Sil BiteELW · Traditional | DiaDent Group International | 03/19/2026SE |
| K253501 | Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set -…ELW · Traditional | Vigodent Indústria E Comercio Ltda | 10/31/2025SE |
| K250969 | Jet Bite; Jet Blue Bite Fast; Jet Blue Bite SuperfastELW · Abbreviated | Dent4you AG | 06/27/2025SE |
| K241924 | Elastic Impression MaterialELW · Abbreviated | Beijing Okvd Biological Technology , Ltd. | 12/27/2024SE |
| K242360 | Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal…ELW · Traditional | Dent4you AG | 11/15/2024SE |
| K233954 | Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-BluELW · Traditional | B&E Korea Co., Ltd. | 02/13/2024SE |
| K223892 | DentMix VPS Impression MaterialELW · Traditional | Innovative Product Brands, Inc. | 04/27/2023SE |
| K213175 | No Stress ImpressELW · Traditional | No Stress Impress, LLC | 01/19/2023SE |
| K214086 | Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite…ELW · Traditional | Genoss Co., Ltd. | 12/15/2022SE |
| K222741 | DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular…ELW · Traditional | Hdi, Inc. | 11/07/2022SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K260805 | Dual CoreEBF · Traditional | 05/11/2026SE |
| K252285 | Well-Root PTKIF · Traditional | 09/19/2025SE |
| 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 |
| K152615 | Vonflex SELW · Traditional | 11/03/2016SE |
| K152518 | Vonflex S PuttyELW · Traditional | 11/30/2015SE |
| K103164 | Vonflex Heavy, Vinflex LightELW · Traditional | 11/10/2010SE |
Questions and answers
When was Vonflex S Bite cleared by the FDA?
Vonflex S Bite (K140966) received a 510(k) decision of Substantially Equivalent on August 15, 2014, 122 days after the submission was received.
What is the product code of K140966?
The FDA product code is ELW – Material, Impression, a Class II (moderate risk) device regulated under 21 CFR 872.3660.