Componeer
FDA 510(k) K112168 · Coltene/Whaledent AG
510(k) numberK112168
Submission
- Device name
- Componeer
- Applicant
- Coltene/Whaledent AG
Cuyahoga Falls, OH, US - Received
- July 28, 2011
- Decision date
- November 21, 2011
- 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 |
|---|---|---|
| K191385 | Brilliant ComponeerEBF · Traditional | 10/29/2019SE |
| K190597 | BRILLIANT EverGlow FlowEBF · Traditional | 06/21/2019SE |
| K181500 | BRILLIANT CriosEBF · Traditional | 08/15/2018SE |
| K160800 | DuoCemEMA · Traditional | 11/16/2016SE |
| K152927 | Brilliant EverglowEBF · Traditional | 04/28/2016SE |
| K152243 | One Coat 7 UniversalKLE · Traditional | 12/09/2015SE |
| K150218 | Fill-Up!EBF · Traditional | 06/23/2015SE |
| K130137 | Biosonic Suvi Piezeoelectric Scaler and PolisherELC · Traditional | 08/23/2013SE |
| K121621 | SolocemEMA · Traditional | 01/08/2013SE |
| K083304 | Temposil 2EMA · Traditional | 02/06/2009SE |
Questions and answers
When was Componeer cleared by the FDA?
Componeer (K112168) received a 510(k) decision of Substantially Equivalent on November 21, 2011, 116 days after the submission was received.
What is the product code of K112168?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.