In Ten-S
FDA 510(k) K011492 · Ivoclar North America, Inc.
510(k) numberK011492
Submission
- Device name
- In Ten-S
- Applicant
- Ivoclar North America, Inc.
Amherst, NY, US - Received
- May 15, 2001
- Decision date
- July 5, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K012174 | Eris Layering MaterialsEIH · Traditional | 08/27/2001SE |
| K011491 | Helioseal Clear ChromaEBC · Traditional | 08/16/2001SE |
| K011490 | Modification to ExciteKLE · Traditional | 06/27/2001SE |
| K011023 | D.Sign 96EJT · Traditional | 05/02/2001SE |
| K011022 | Biouniversal PDFEJT · Traditional | 05/02/2001SE |
| K010381 | D.Sign 30EJH · Traditional | 03/06/2001SE |
| K010250 | Tetric Ceram HBEBF · Traditional | 02/28/2001SE |
| K003293 | Excite DSCKLE · Traditional | 02/06/2001SE |
| K003407 | Systemp.Desensitizer (Vivadent.Desensitizer)EMA · Traditional | 01/26/2001SE |
| K003635 | DW 276 #3EJT · Traditional | 12/22/2000SE |
Questions and answers
When was In Ten-S cleared by the FDA?
In Ten-S (K011492) received a 510(k) decision of Substantially Equivalent on July 5, 2001, 51 days after the submission was received.
What is the product code of K011492?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.