G aenial Universal Injectable II
FDA 510(k) K251946 · GC America, Inc.
510(k) numberK251946
Submission
- Device name
- G aenial Universal Injectable II
- Applicant
- GC America, Inc.
Alsip, IL, US - Received
- June 25, 2025
- Decision date
- August 29, 2025
- 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 |
|---|---|---|
| K262202 | Cerasmart ForteEBF · Traditional | 09/10/2026SE |
| K253317 | Cytrans ElashieldLYC · Traditional | 07/06/2026SE |
| K261246 | SRGC-06EBF · Traditional | 06/18/2026SE |
| K254109 | G-Cem UniversalEMA · Traditional | 05/18/2026SE |
| K251124 | G-Bond UniversalKLE · Traditional | 10/02/2025SE |
| K250953 | Equia LC OneEMA · Traditional | 09/19/2025SE |
| K200798 | G-Cem OneEMA · Traditional | 11/24/2020SE |
| K200682 | BZF-29KLE · Traditional | 10/02/2020SE |
| K192597 | Cytrans GranulesLYC · Abbreviated | 08/17/2020SE |
| K193113 | GC Temp PrintEBG · Traditional | 07/09/2020SE |
Questions and answers
When was G aenial Universal Injectable II cleared by the FDA?
G aenial Universal Injectable II (K251946) received a 510(k) decision of Substantially Equivalent on August 29, 2025, 65 days after the submission was received.
What is the product code of K251946?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.