TrusFIL-Flow Flowable Composite Restorative
FDA 510(k) K221510 · Rizhao Huge Biomaterials Company, Ltd.
510(k) numberK221510
Submission
- Device name
- TrusFIL-Flow Flowable Composite Restorative
- Applicant
- Rizhao Huge Biomaterials Company, Ltd.
Rizhao City, CN - Received
- May 24, 2022
- Decision date
- October 12, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K252785 | TopCEM Vigor SA Self-Adhesive Resin CementEMA · Traditional | 12/12/2025SE |
| K251271 | TempFIT Temporary Crown and Bridge ResinEBG · Traditional | 06/23/2025SE |
| K242572 | TopCEM-Try in Veneer Try-in GelEBF · Traditional | 12/20/2024SE |
| K242530 | HF-Etchant Hydrofluoric Acid Etching GelKLE · Traditional | 12/20/2024SE |
| K242749 | TopCEM Ceramic Primer Ceramic Coupling AgentKLE · Traditional | 11/08/2024SE |
| K241204 | TopCEM-Veneer Light Cure Veneer CementEMA · Traditional | 06/28/2024SE |
| K233082 | TopCEM Dual Cure Resin CementEBF · Traditional | 12/22/2023SE |
| K230455 | Enamel Coating ResinEBC · Traditional | 07/25/2023SE |
| K221450 | Phosphoric Acid Etching GelKLE · Traditional | 09/12/2022SE |
| K202063 | TrusFIL Universal Composite RestorativeEBF · Traditional | 10/06/2021SE |
Questions and answers
When was TrusFIL-Flow Flowable Composite Restorative cleared by the FDA?
TrusFIL-Flow Flowable Composite Restorative (K221510) received a 510(k) decision of Substantially Equivalent on October 12, 2022, 141 days after the submission was received.
What is the product code of K221510?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.