Calcium Bridge
FDA 510(k) K153191 · Denali Corporation
510(k) numberK153191
Submission
- Device name
- Calcium Bridge
- Applicant
- Denali Corporation
Hanover, MA, US - Received
- November 3, 2015
- Decision date
- February 26, 2016
- 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 |
|---|---|---|
| K151945 | Triumph Resin DamEIE · Traditional | 02/18/2016SE |
| K152322 | Resolve 2.0PME · Traditional | 12/16/2015SE |
| K141503 | Denali 501CEMENTEMA · Traditional | 11/10/2014SE |
| K132393 | Cercom II CementEMA · Traditional | 03/14/2014SE |
| K073101 | Auraveneer CementEMA · Traditional | 01/17/2008SE |
| K071158 | Auralay Pit & Fissure SealantEBC · Traditional | 06/05/2007SE |
| K070702 | Fusion Resin Cement and Core KitEBF · Traditional | 05/10/2007SE |
| K070693 | Auravue Pit & Fissure SealantEBF · Traditional | 05/09/2007SE |
Questions and answers
When was Calcium Bridge cleared by the FDA?
Calcium Bridge (K153191) received a 510(k) decision of Substantially Equivalent on February 26, 2016, 115 days after the submission was received.
What is the product code of K153191?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.