BEAUTIFIL Flow Plus X
FDA 510(k) K172530 · Shofu Dental Corporation
510(k) numberK172530
Submission
- Device name
- BEAUTIFIL Flow Plus X
- Applicant
- Shofu Dental Corporation
San Marcos, CA, US - Received
- August 21, 2017
- Decision date
- December 6, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K262202 | Cerasmart ForteEBF · Traditional | GC America, Inc. | 09/10/2026SE |
| K261695 | Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)EBF · Traditional | Guilin Kevin Peter Technology Co., Ltd. | 08/31/2026SE |
| 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 |
|---|---|---|
| K252808 | GlasIonomer FX-LCEMA · Traditional | 12/09/2025SE |
| K252165 | Zirconomer PEMA · Traditional | 10/28/2025SE |
| K251470 | ResiCem EXEMA · Traditional | 07/11/2025SE |
| K251578 | Beautifil IIEBF · Traditional | 05/27/2025SE |
| K233161 | BeautiLink SAEMA · Traditional | 09/28/2023SE |
| K222253 | GlasIonomer FX ULTRAEMA · Traditional | 09/22/2022SE |
| K213965 | BeautiBond XtremeKLE · Traditional | 03/18/2022SE |
| K212939 | Vintage Prime PressEIH · Traditional | 03/18/2022SE |
| K200470 | Shofu Block HC HardEBF · Traditional | 02/05/2021SE |
| K191794 | Vintage Art UniversalEIH · Traditional | 10/03/2019SE |
Questions and answers
When was BEAUTIFIL Flow Plus X cleared by the FDA?
BEAUTIFIL Flow Plus X (K172530) received a 510(k) decision of Substantially Equivalent on December 6, 2017, 107 days after the submission was received.
What is the product code of K172530?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.