Zeon Composite Resin System
FDA 510(k) K820006 · National Patent Development Corp.
510(k) numberK820006
Submission
- Device name
- Zeon Composite Resin System
- Applicant
- National Patent Development Corp.
Mchenry, IL, US - Received
- January 4, 1982
- Decision date
- January 22, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
More from Hangzhou SHINING3D Dental Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K843974 | Variable Temperature Cautery DeviceGEI · Traditional | 02/26/1985SE |
| K832699 | Hydron Wound Dressing Fast Seat KitFRO · Traditional | 04/27/1984SE |
| K822793 | Pio Root Canal IndicatorEIL · Traditional | 10/22/1982SE |
| K820028 | Zeon Composite Resin Light Cure SysEBF · Traditional | 03/11/1982SE |
| K811446 | Hydron Wound Dressing KitKMF · Traditional | 06/12/1981SE |
| K801484 | Root Canal Filling Applicator NeedlesEIC · Traditional | 07/21/1980SE |
| K801483 | Mark IV SyringeEIC · Traditional | 07/21/1980SE |
| K801482 | Hydron Root Canal Filling MaterialKIF · Traditional | 07/21/1980SE |
| K792136 | Hypo-Allergenic Plastic TapeFPX · Traditional | 01/16/1980SE |
| K792227 | Multi-Ad Fluid Dispensing SystemKYX · Traditional | 12/20/1979SE |
Questions and answers
When was Zeon Composite Resin System cleared by the FDA?
Zeon Composite Resin System (K820006) received a 510(k) decision of Substantially Equivalent on January 22, 1982, 18 days after the submission was received.
What is the product code of K820006?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.