Degufill (R) M
FDA 510(k) K901868 · Degussa AG
510(k) numberK901868
Submission
- Device name
- Degufill (R) M
- Applicant
- Degussa AG
West Germany, DE - Received
- April 24, 1990
- Decision date
- August 14, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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.
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|---|---|---|
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| K972910 | Pors on LiteEJT · Traditional | 10/14/1997SE |
| K960256 | Degudent LSEJT · Traditional | 02/21/1996SE |
| K960226 | DG 88EJT · Traditional | 02/14/1996SE |
| K960104 | Biocclus 4EJT · Traditional | 02/06/1996SE |
| K955465 | DeguprintELW · Traditional | 12/28/1995SE |
| K955118 | Degubond X-Lite PlusEJT · Traditional | 12/11/1995SE |
| K955027 | Degubond X-LiteEJT · Traditional | 12/01/1995SE |
| K953344 | Degubond UltraEJT · Traditional | 08/25/1995SE |
| K951789 | Palliag NF IVEJT · Traditional | 06/14/1995SE |
Questions and answers
When was Degufill (R) M cleared by the FDA?
Degufill (R) M (K901868) received a 510(k) decision of Substantially Equivalent on August 14, 1990, 112 days after the submission was received.
What is the product code of K901868?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.