Infinix Universal Composite
FDA 510(k) K182921 · Nobio , Ltd.
510(k) numberK182921
Submission
- Device name
- Infinix Universal Composite
- Applicant
- Nobio , Ltd.
Kadima, IL - Received
- October 19, 2018
- Decision date
- September 13, 2019
- 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 |
|---|---|---|
| K201010 | Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow CompositeEBF · Traditional | 08/14/2020SE |
| K183391 | Novidia Universal BondKLE · Traditional | 09/24/2019SE |
| K182714 | Novidia Bulk Fill Flow CompositeEBF · Traditional | 07/12/2019SE |
| K182580 | Novidia Flowable CompositeEBF · Traditional | 07/03/2019SE |
Questions and answers
When was Infinix Universal Composite cleared by the FDA?
Infinix Universal Composite (K182921) received a 510(k) decision of Substantially Equivalent on September 13, 2019, 329 days after the submission was received.
What is the product code of K182921?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.