DMC Composite
FDA 510(k) K081695 · Kerr Corp.
510(k) numberK081695
Submission
- Device name
- DMC Composite
- Applicant
- Kerr Corp.
Orange, CA, US - Received
- June 17, 2008
- Decision date
- August 12, 2008
- 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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K252890 | ZenSeal ProKIF · Traditional | 01/07/2026SE |
| K222830 | Rainbow 360KLE · Traditional | 01/12/2023SE |
| K221255 | SimpliShade Bulk Fill, SimpliShade Bulk Fill FlowEBF · Traditional | 08/31/2022SE |
| K191548 | Nexus Universal Self-CureEMA · Traditional | 10/11/2019SE |
| K182162 | OptiBond eXTRa UniversalKLE · Traditional | 11/07/2018SE |
| K162948 | Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction…MVL · Traditional | 08/08/2017SE |
| K163064 | Demi UltraEBZ · Special | 07/18/2017SE |
| K162536 | GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum…MVL · Traditional | 02/03/2017SE |
| K162164 | GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction CordMVL · Traditional | 01/13/2017SE |
| K162436 | EndoVac PureNYL · Traditional | 12/21/2016SE |
Questions and answers
When was DMC Composite cleared by the FDA?
DMC Composite (K081695) received a 510(k) decision of Substantially Equivalent on August 12, 2008, 56 days after the submission was received.
What is the product code of K081695?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.