C&B Ceramic; C&B Permanent; C&B Interim
FDA 510(k) K233273 · Prevest Denpro Limited
510(k) numberK233273
Submission
- Device name
- C&B Ceramic; C&B Permanent; C&B Interim
- Applicant
- Prevest Denpro Limited
Bari Brahmana, IN - Received
- September 29, 2023
- Decision date
- November 27, 2024
- 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 |
More from Hangzhou SHINING3D Dental Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K231263 | Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NTEBF · Traditional | 01/05/2024SE |
| K231696 | Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew UniversalKLE · Traditional | 08/11/2023SE |
| K213244 | Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil…ELW · Traditional | 09/09/2022SE |
| K212563 | CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra…KIF · Traditional | 05/23/2022SE |
| K212475 | Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)EJK · Traditional | 05/13/2022SE |
| K200555 | Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior…EMA · Traditional | 05/13/2021SE |
Questions and answers
When was C&B Ceramic; C&B Permanent; C&B Interim cleared by the FDA?
C&B Ceramic; C&B Permanent; C&B Interim (K233273) received a 510(k) decision of Substantially Equivalent on November 27, 2024, 425 days after the submission was received.
What is the product code of K233273?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.