Signum opaque F
FDA 510(k) K230644 · Kulzer, LLC
510(k) numberK230644
Submission
- Device name
- Signum opaque F
- Applicant
- Kulzer, LLC
South Bend, IN, US - Received
- March 8, 2023
- Decision date
- September 7, 2023
- 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 |
|---|---|---|
| K260783 | Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow OneEBF · Traditional | 03/11/2026SE |
| K254063 | iCEM Universal PlusEMA · Abbreviated | 12/19/2025SE |
| K243910 | RetraxilMVL · Traditional | 09/24/2025SE |
| K240660 | Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite…EBF · Traditional | 09/17/2024SE |
| K233868 | dima Print Teeth & TempEBG · Traditional | 05/23/2024SE |
| K220605 | Venus Bulk Flow ONEEBF · Special | 04/21/2022SE |
| K905058 | Palavit LEBH · Traditional | 06/06/1991SE |
| K904928 | Palavit GLCEGD · Traditional | 06/06/1991SE |
| K910263 | CharismaEBF · Traditional | 06/03/1991SE |
| K910719 | Silicoater MDEMA · Traditional | 04/29/1991SE |
Questions and answers
When was Signum opaque F cleared by the FDA?
Signum opaque F (K230644) received a 510(k) decision of Substantially Equivalent on September 7, 2023, 183 days after the submission was received.
What is the product code of K230644?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.