Opus Bulk Fill APS, Opus Bulk Fill Flow APS
FDA 510(k) K190758 · Dentscare Ltda
510(k) numberK190758
Submission
- Device name
- Opus Bulk Fill APS, Opus Bulk Fill Flow APS
- Applicant
- Dentscare Ltda
Joinville, BR - Received
- March 25, 2019
- Decision date
- September 4, 2019
- 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 |
|---|---|---|
| K231859 | PrimmaArtEBG · Traditional | 11/26/2024SE |
| K232994 | Vittra APS Unique FlowEBF · Traditional | 10/18/2024SE |
| K210231 | Vittra APS UniqueEBF · Traditional | 10/14/2021SE |
| K201707 | Opallis, Opallis FlowEBF · Traditional | 12/22/2020SE |
| K192682 | Orthocem, Ortho BiteDYH · Traditional | 08/14/2020SE |
| K191389 | Allcem Veneer APSEBF · Traditional | 02/25/2020SE |
| K191306 | Llis, Vittra APSEBF · Traditional | 12/16/2019SE |
| K183424 | Ambar, Ambar APS, Ambar Universal APSKLE · Traditional | 12/13/2019SE |
| K183465 | Allcem, Allcem CoreEMA · Traditional | 11/02/2019SE |
Questions and answers
When was Opus Bulk Fill APS, Opus Bulk Fill Flow APS cleared by the FDA?
Opus Bulk Fill APS, Opus Bulk Fill Flow APS (K190758) received a 510(k) decision of Substantially Equivalent on September 4, 2019, 163 days after the submission was received.
What is the product code of K190758?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.