U-Cem Premium & MAZIC Cem
FDA 510(k) K193260 · Vericom Co., Ltd.
510(k) numberK193260
Submission
- Device name
- U-Cem Premium & MAZIC Cem
- Applicant
- Vericom Co., Ltd.
Chuncheon-Si, KR - Received
- November 26, 2019
- Decision date
- August 21, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K254201 | Any-CemEMA · Traditional | Mediclus Co., Ltd. | 08/13/2026SE |
| K261937 | PacTemp Automix NEEMA · Traditional | The Belport Company Inc., DBA Gingi-Pak | 08/07/2026SE |
| K261166 | Dia-CemEMA · Traditional | DiaDent Group International | 07/09/2026SE |
| K254109 | G-Cem UniversalEMA · Traditional | GC America, Inc. | 05/18/2026SE |
| K253337 | REGEN Bioactive CementEMA · Traditional | Inter-Med, Inc. | 04/15/2026SE |
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| K254063 | iCEM Universal PlusEMA · Abbreviated | Kulzer, LLC | 12/19/2025SE |
| K252785 | TopCEM Vigor SA Self-Adhesive Resin CementEMA · Traditional | Rizhao Huge Biomaterials Company, Ltd. | 12/12/2025SE |
| K252808 | GlasIonomer FX-LCEMA · Traditional | Shofu Dental Corporation | 12/09/2025SE |
| K252165 | Zirconomer PEMA · Traditional | Shofu Dental Corporation | 10/28/2025SE |
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| K203672 | MAZIC Claro CAD and MAZIC Claro PressEIH · Traditional | 07/01/2021SE |
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| 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 |
| K140966 | Vonflex S BiteELW · Traditional | 08/15/2014SE |
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Questions and answers
When was U-Cem Premium & MAZIC Cem cleared by the FDA?
U-Cem Premium & MAZIC Cem (K193260) received a 510(k) decision of Substantially Equivalent on August 21, 2020, 269 days after the submission was received.
What is the product code of K193260?
The FDA product code is EMA – Cement, Dental, a Class II (moderate risk) device regulated under 21 CFR 872.3275.