Stela Automix System
FDA 510(k) K222581 · Sdi Limited
510(k) numberK222581
Submission
- Device name
- Stela Automix System
- Applicant
- Sdi Limited
Melbourne, AU - Received
- August 26, 2022
- Decision date
- October 28, 2022
- 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 |
|---|---|---|
| K222583 | Stela Capsule SystemEBF · Traditional | 10/28/2022SE |
| K214118 | Riva Cem AutomixEMA · Traditional | 08/30/2022SE |
| K191656 | ZipbondKLE · Traditional | 12/02/2019SE |
| K172047 | Riva StarPHR · Traditional | 04/11/2018SE |
| K102984 | AuraEBF · Traditional | 12/08/2010SE |
| K081273 | Ultracaps SOIV · Traditional | 07/10/2008SE |
| K073043 | Set PPEMA · Traditional | 12/14/2007SE |
| K833176 | Sdi Surgical DrapeKKX · Traditional | 04/04/1984SE |
Questions and answers
When was Stela Automix System cleared by the FDA?
Stela Automix System (K222581) received a 510(k) decision of Substantially Equivalent on October 28, 2022, 63 days after the submission was received.
What is the product code of K222581?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.