R&D Series Nova Compo N
FDA 510(k) K192178 · Imicryl Dis Malzemeleri Sanayi VE Ticaret AS
510(k) numberK192178
Submission
- Device name
- R&D Series Nova Compo N
- Applicant
- Imicryl Dis Malzemeleri Sanayi VE Ticaret AS
Konya, TR - Received
- August 12, 2019
- Decision date
- December 20, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code EBF
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|---|---|---|---|
| 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 |
|---|---|---|
| K220077 | IMICRYL Composite, Composite Flow MaterialsEBF · Traditional | 08/09/2022SE |
| K213609 | NOVA RESIN dual cure, self adhesive resin cementEMA · Traditional | 08/09/2022SE |
| K210473 | Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass…EMA · Traditional | 11/02/2021SE |
| K192913 | R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single DoseKLE · Traditional | 01/19/2021SE |
Questions and answers
When was R&D Series Nova Compo N cleared by the FDA?
R&D Series Nova Compo N (K192178) received a 510(k) decision of Substantially Equivalent on December 20, 2019, 130 days after the submission was received.
What is the product code of K192178?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.