Grandio disc multicolor
FDA 510(k) K261357 · Voco GmbH
510(k) numberK261357
Submission
- Device name
- Grandio disc multicolor
- Applicant
- Voco GmbH
Cuxhaven, DE - Received
- April 24, 2026
- Decision date
- April 27, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 |
| K261356 | Dura-CrownEBF · Special | Hangzhou SHINING3D Dental Technology Co., Ltd. | 04/27/2026SE |
| K260152 | Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT)EBF · Traditional | Mmtech Projetos Tecnologicos Importacao E… | 04/23/2026SE |
More from Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda.
| 510(k) | Device | Decision |
|---|---|---|
| K252073 | VOCO Profluorid Varnish + BioMinLBH · Traditional | 05/01/2026SE |
| K252606 | Bifix Veneer LC, Bifix Veneer Try-InEMA · Traditional | 03/20/2026SE |
| K251390 | MTA vptKIF · Traditional | 07/03/2025SE |
| K251239 | GrandioSO UnlimitedEBF · Special | 05/21/2025SE |
| K231817 | AlignerFlow LCDYH · Traditional | 12/01/2023SE |
| K231591 | V-Print c&b tempPOW · Traditional | 07/31/2023SE |
| K230877 | Admira Fusion 5EBF · Traditional | 07/13/2023SE |
| K220236 | V-Print dentbaseEBI · Traditional | 09/21/2022SE |
| K220640 | Bifix Hybrid Abutment CementEMA · Traditional | 08/23/2022SE |
| K220743 | CediTECEBI · Traditional | 07/05/2022SE |
Questions and answers
When was Grandio disc multicolor cleared by the FDA?
Grandio disc multicolor (K261357) received a 510(k) decision of Substantially Equivalent on April 27, 2026, 3 days after the submission was received.
What is the product code of K261357?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.