Trinia
FDA 510(k) K133608 · Bicon, LLC
510(k) numberK133608
Submission
- Device name
- Trinia
- Applicant
- Bicon, LLC
Boston, MA, US - Received
- November 25, 2013
- Decision date
- March 14, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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 |
|---|---|---|
| K143524 | Fiber Disks and Blocks (TRINIA)EBF · Traditional | 06/02/2015SE |
| K101849 | Bicon Dental Implant System 3.0MM Bicon Dental ImplantDZE · Traditional | 10/01/2010SE |
| K092035 | Bicon Implants with a 2.5MM Internal ConnectionDZE · Traditional | 10/15/2009SE |
| K073368 | 5.0 X 5.0MM Dental Implant and 6.0 X 5.0 Dental ImplantDZE · Traditional | 10/10/2008SE |
| K062044 | The 5.0 X 6.0MM Dental ImplantDZE · Traditional | 11/21/2006SE |
| K051091 | SynthograftLYC · Traditional | 09/01/2005SE |
| K050712 | 4.5.* 6.0MM Dental Implant and 6.0*6.0 MM Dental ImplantDZE · Traditional | 04/22/2005SE |
| K050408 | Bicon Orthodontic Implant SystemDZE · Traditional | 04/07/2005SE |
| K031568 | Biconite Surface TreatmentDZE · Traditional | 11/23/2004SE |
| K042637 | The 5.0 X 6.0MM Dental ImplantDZE · Traditional | 11/15/2004SE |
Questions and answers
When was Trinia cleared by the FDA?
Trinia (K133608) received a 510(k) decision of Substantially Equivalent on March 14, 2014, 109 days after the submission was received.
What is the product code of K133608?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.