3Delta Crown
FDA 510(k) K211804 · Deltamed GmbH
510(k) numberK211804
Submission
- Device name
- 3Delta Crown
- Applicant
- Deltamed GmbH
Friedberg, DE - Received
- June 11, 2021
- Decision date
- December 6, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K243720 | 3Delta UNlimitedEBF · Traditional | 12/18/2024SE |
| K230341 | AcrifixEBI · Traditional | 04/06/2023SE |
| K212541 | 3Delta Denture Base - 3Delta Denture Bond - 3Delta Denture FixEBI · Traditional | 01/10/2022SE |
| K200039 | P pro Crown & BridgeEBG · Traditional | 07/31/2020SE |
| K102776 | Extra-Oral, Additive Computer Aided Manufacture and Curing SystemEBG · Traditional | 02/18/2011SE |
Questions and answers
When was 3Delta Crown cleared by the FDA?
3Delta Crown (K211804) received a 510(k) decision of Substantially Equivalent on December 6, 2021, 178 days after the submission was received.
What is the product code of K211804?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.