Microfill 13
FDA 510(k) K022972 · Ab Ardent
510(k) numberK022972
Submission
- Device name
- Microfill 13
- Applicant
- Ab Ardent
Tonawanda, NY, US - Received
- September 6, 2002
- Decision date
- November 22, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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 |
|---|---|---|
| K131753 | MeridianEBF · Abbreviated | 11/14/2013SE |
| K040465 | Latit FlowEBF · Traditional | 07/20/2004SE |
| K022971 | Microhybrid 11EBF · Traditional | 11/25/2002SE |
| K022975 | Etching 15EBF · Traditional | 11/22/2002SE |
| K022974 | Microhybrid 12EBF · Traditional | 11/22/2002SE |
| K022973 | Adhesive 14KLE · Traditional | 11/22/2002SE |
| K020452 | High Silver ConventionalEJJ · Traditional | 05/07/2002SE |
| K011801 | Futura Topcap Non GAMMA-2EJJ · Traditional | 08/16/2001SE |
| K991974 | Futura Glass Ionomer Silver ReinforcedEMA · Traditional | 09/17/1999SE |
| K982460 | Vivacap HREJJ · Traditional | 08/24/1998SE |
Questions and answers
When was Microfill 13 cleared by the FDA?
Microfill 13 (K022972) received a 510(k) decision of Substantially Equivalent on November 22, 2002, 77 days after the submission was received.
What is the product code of K022972?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.