Tetric Evoflow Bulk Fill
FDA 510(k) K150393 · Ivoclar Vivadent, AG
510(k) numberK150393
Submission
- Device name
- Tetric Evoflow Bulk Fill
- Applicant
- Ivoclar Vivadent, AG
Schaan, LI - Received
- February 18, 2015
- Decision date
- June 9, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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 |
|---|---|---|
| K261485 | Tetric plus Fill;Tetric plus FlowEBF · Traditional | 07/01/2026SE |
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| K252450 | Adhese 2KLE · Traditional | 03/05/2026SE |
| K233995 | Ivotion Base PrintEBI · Traditional | 02/23/2024SE |
| K210804 | Adhese Universal DC, Cention PrimerKLE · Traditional | 06/07/2022SE |
| K211916 | IPS e.max OneEIH · Traditional | 08/20/2021SE |
| K193193 | Telio CAD Abutment Solutions- extra systemsNHA · Abbreviated | 11/16/2020SE |
| K191453 | Cervitec FLBH · Traditional | 02/11/2020SE |
| K191448 | Barrier SleevesPEM · Traditional | 10/08/2019SE |
| K191382 | IPS e.max CAD Abutment Solutions- extra systemsNHA · Abbreviated | 08/26/2019SE |
Questions and answers
When was Tetric Evoflow Bulk Fill cleared by the FDA?
Tetric Evoflow Bulk Fill (K150393) received a 510(k) decision of Substantially Equivalent on June 9, 2015, 111 days after the submission was received.
What is the product code of K150393?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.