Ezfil
FDA 510(k) K191991 · Meta Biomed Co., Ltd.
510(k) numberK191991
Submission
- Device name
- Ezfil
- Applicant
- Meta Biomed Co., Ltd.
Cheongju-Si, KR - Received
- July 25, 2019
- Decision date
- March 5, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code EBF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K242014 | Jet Flow BulkEBF · Traditional | 10/08/2024SE |
| K232299 | CeraPuttyKIF · Traditional | 09/29/2023SE |
| K230010 | ADSEAL PlusKIF · Traditional | 04/13/2023SE |
| K230009 | EZ Bond UniversalKLE · Traditional | 03/03/2023SE |
| K210904 | Metapaste PlusKIF · Traditional | 06/30/2021SE |
| K202617 | Metapex PlusKIF · Traditional | 04/14/2021SE |
| 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 Ezfil cleared by the FDA?
Ezfil (K191991) received a 510(k) decision of Substantially Equivalent on March 5, 2020, 224 days after the submission was received.
What is the product code of K191991?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.