SonicFill 2
FDA 510(k) K143209 · Sybron Dental Specialties
510(k) numberK143209
Submission
- Device name
- SonicFill 2
- Applicant
- Sybron Dental Specialties
Orange, CA, US - Received
- November 10, 2014
- Decision date
- February 5, 2015
- 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 |
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| K153067 | Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT XpressKIF · Traditional | 07/27/2016SE |
| K152956 | Pulp Canal Sealer, Pulp Canal Sealer EWTKIF · Traditional | 05/06/2016SE |
| K152959 | Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringesKIF · Special | 04/14/2016SE |
| K151526 | Zone, ZoneFree, Zone A1EMA · Traditional | 09/10/2015SE |
| K151332 | Nexus Universal, Nexus Universal ChromaEMA · Abbreviated | 08/17/2015SE |
| K150559 | Life Fast Set, Life Regular SetEJK · Special | 06/19/2015SE |
| K130869 | Take 1 AdvanceELW · Traditional | 05/30/2013SE |
Questions and answers
When was SonicFill 2 cleared by the FDA?
SonicFill 2 (K143209) received a 510(k) decision of Substantially Equivalent on February 5, 2015, 87 days after the submission was received.
What is the product code of K143209?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.