Omnichroma Flow Bulk
FDA 510(k) K203598 · Tokuyama Dental Corporation
510(k) numberK203598
Submission
- Device name
- Omnichroma Flow Bulk
- Applicant
- Tokuyama Dental Corporation
Taitou-Ku, JP - Received
- December 9, 2020
- Decision date
- February 3, 2021
- 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 |
|---|---|---|
| K203760 | Tokuyama Universal Bond IIKLE · Traditional | 05/25/2021SE |
| K193537 | Omnichroma FlowEBF · Traditional | 08/19/2020SE |
| K190940 | Tokuyama Rebase IIIEBI · Traditional | 10/04/2019SE |
| K180613 | Estelite Universal FlowEBF · Traditional | 07/12/2018SE |
| K173275 | OmnichromaEBF · Traditional | 02/27/2018SE |
| K171226 | Tokuyama Universal BondKLE · Traditional | 11/28/2017SE |
| K170549 | Tokuyama CuregraceEBI · Traditional | 07/05/2017SE |
| K161353 | ESTELITE BULK FILL FlowEBF · Traditional | 04/03/2017SE |
| K150727 | EstecemEMA · Traditional | 06/17/2015SE |
| K112445 | Sofreliner Tough SEBI · Traditional | 10/28/2011SE |
Questions and answers
When was Omnichroma Flow Bulk cleared by the FDA?
Omnichroma Flow Bulk (K203598) received a 510(k) decision of Substantially Equivalent on February 3, 2021, 56 days after the submission was received.
What is the product code of K203598?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.