Jet Flow Bulk
FDA 510(k) K242014 · Meta Biomed Co., Ltd.
510(k) numberK242014
Submission
- Device name
- Jet Flow Bulk
- Applicant
- Meta Biomed Co., Ltd.
Cheongju-Si, KR - Received
- July 10, 2024
- Decision date
- October 8, 2024
- 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 |
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| K230009 | EZ Bond UniversalKLE · Traditional | 03/03/2023SE |
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| K202617 | Metapex PlusKIF · Traditional | 04/14/2021SE |
| K191991 | EzfilEBF · Traditional | 03/05/2020SE |
| K190724 | MD-Temp PlusEBG · Traditional | 07/03/2019SE |
| K190503 | CeraSealKIF · Traditional | 06/07/2019SE |
| K190510 | GuttaSilKIF · Traditional | 05/29/2019SE |
| K181689 | NexcompEBF · Traditional | 11/15/2018SE |
Questions and answers
When was Jet Flow Bulk cleared by the FDA?
Jet Flow Bulk (K242014) received a 510(k) decision of Substantially Equivalent on October 8, 2024, 90 days after the submission was received.
What is the product code of K242014?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.