Bulk Fill Flowable Composite
FDA 510(k) K141994 · Novocol, Inc.
510(k) numberK141994
Submission
- Device name
- Bulk Fill Flowable Composite
- Applicant
- Novocol, Inc.
Louisville, CO, US - Received
- July 22, 2014
- Decision date
- November 14, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K130601 | Bioroot RCSKIF · Abbreviated | 10/17/2013SE |
| K120237 | Bpa-Free Microhybid CompositeEBF · Abbreviated | 12/11/2012SE |
| K120283 | Dimer Dual Cure Permanent/Temporary Resin CementEMA · Abbreviated | 07/31/2012SE |
| K120619 | Orthodontic Flowable Bracket AdhesiveDYH · Abbreviated | 05/21/2012SE |
| K110484 | Self Cure Temporary Crown and Bridge MaterialEBG · Traditional | 05/17/2011SE |
| K092501 | Light-Activated Low-Stress Thiol-Ene Composite Restorative MaterialEBF · Abbreviated | 11/12/2009SE |
| K072150 | Dimer Acid Derived Nano-Hybrid Composite Restorative MaterialEBF · Abbreviated | 09/13/2007SE |
| K040343 | Temp FEMA · Traditional | 08/03/2004SE |
Questions and answers
When was Bulk Fill Flowable Composite cleared by the FDA?
Bulk Fill Flowable Composite (K141994) received a 510(k) decision of Substantially Equivalent on November 14, 2014, 115 days after the submission was received.
What is the product code of K141994?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.