D/C Core Material
FDA 510(k) K010475 · Parkell, Inc.
510(k) numberK010475
Submission
- Device name
- D/C Core Material
- Applicant
- Parkell, Inc.
Farmingdale, NY, US - Received
- February 20, 2001
- Decision date
- May 7, 2001
- 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 |
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| 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 |
|---|---|---|
| K243254 | Parkell Pit and Fissure SealantEBC · Abbreviated | 08/08/2025SE |
| K210259 | Parkell Self-Adhesive CementEMA · Traditional | 01/20/2022SE |
| K191103 | Parkell Desensitizer GelEJK · Traditional | 11/22/2019SE |
| K190930 | SmarTemp X1EBG · Traditional | 09/05/2019SE |
| K182296 | HyperFil-LVEBF · Traditional | 12/14/2018SE |
| K172176 | Parkell Universal AdhesiveKLE · Traditional | 11/21/2017SE |
| K151518 | Brush&Bond PlusKLE · Traditional | 09/18/2015SE |
| K142848 | Eazy PrimerKLE · Traditional | 02/24/2015SE |
| K132115 | Absolute Dentin 2EBF · Traditional | 06/25/2014SE |
| K113839 | Retract Gingival Retraction/Hemostatic PasteMVL · Traditional | 04/12/2012SE |
Questions and answers
When was D/C Core Material cleared by the FDA?
D/C Core Material (K010475) received a 510(k) decision of Substantially Equivalent on May 7, 2001, 76 days after the submission was received.
What is the product code of K010475?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.