VisCalor
FDA 510(k) K201307 · Voco GmbH
510(k) numberK201307
Submission
- Device name
- VisCalor
- Applicant
- Voco GmbH
Cuxhaven, DE - Received
- May 15, 2020
- Decision date
- July 8, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
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| K262202 | Cerasmart ForteEBF · Traditional | GC America, Inc. | 09/10/2026SE |
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| K262228 | Transcend Bulk Fill Flowable CompositeEBF · Traditional | Ultradent Products, Inc. | 07/01/2026SE |
| K261485 | Tetric plus Fill;Tetric plus FlowEBF · Traditional | Ivoclar Vivadent, Inc. | 07/01/2026SE |
| K261246 | SRGC-06EBF · Traditional | GC America, Inc. | 06/18/2026SE |
| K261093 | DiafilEBF · Traditional | DiaDent Group International | 06/02/2026SE |
| K261071 | DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW…EBF · Traditional | DiaDent Group International | 05/19/2026SE |
| K260805 | Dual CoreEBF · Traditional | Vericom Co., Ltd. | 05/11/2026SE |
| K261357 | Grandio disc multicolorEBF · Traditional | Voco GmbH | 04/27/2026SE |
| K261356 | Dura-CrownEBF · Special | Hangzhou SHINING3D Dental Technology Co., Ltd. | 04/27/2026SE |
More from Hangzhou SHINING3D Dental Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K252073 | VOCO Profluorid Varnish + BioMinLBH · Traditional | 05/01/2026SE |
| K261357 | Grandio disc multicolorEBF · Traditional | 04/27/2026SE |
| K252606 | Bifix Veneer LC, Bifix Veneer Try-InEMA · Traditional | 03/20/2026SE |
| K251390 | MTA vptKIF · Traditional | 07/03/2025SE |
| K251239 | GrandioSO UnlimitedEBF · Special | 05/21/2025SE |
| K231817 | AlignerFlow LCDYH · Traditional | 12/01/2023SE |
| K231591 | V-Print c&b tempPOW · Traditional | 07/31/2023SE |
| K230877 | Admira Fusion 5EBF · Traditional | 07/13/2023SE |
| K220236 | V-Print dentbaseEBI · Traditional | 09/21/2022SE |
| K220640 | Bifix Hybrid Abutment CementEMA · Traditional | 08/23/2022SE |
Questions and answers
When was VisCalor cleared by the FDA?
VisCalor (K201307) received a 510(k) decision of Substantially Equivalent on July 8, 2020, 54 days after the submission was received.
What is the product code of K201307?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.