Metal Opaquer
FDA 510(k) K110859 · Apex Dental Materials, Inc.
510(k) numberK110859
Submission
- Device name
- Metal Opaquer
- Applicant
- Apex Dental Materials, Inc.
Lake Zurich, IL, US - Received
- March 28, 2011
- Decision date
- June 23, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| 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 |
|---|---|---|
| K190998 | BA Pit & Fissure SealantEBC · Abbreviated | 11/08/2019SE |
| K161077 | RnD TE and RnD SEKLE · Traditional | 03/17/2017SE |
| K131043 | Apex Universal AdhesiveKLE · Traditional | 09/10/2013SE |
| K131049 | ZRPKLE · Traditional | 08/27/2013SE |
| K120620 | Clean and BoostKLE · Traditional | 05/31/2012SE |
| K092539 | SeamfreeEBF · Traditional | 10/01/2009SE |
| K091647 | InjectafilEBF · Traditional | 09/21/2009SE |
| K062157 | ConformEBF · Traditional | 10/13/2006SE |
| K061981 | SurpassKLE · Abbreviated | 07/31/2006SE |
| K053103 | InterfaceKLE · Abbreviated | 02/01/2006SE |
Questions and answers
When was Metal Opaquer cleared by the FDA?
Metal Opaquer (K110859) received a 510(k) decision of Substantially Equivalent on June 23, 2011, 87 days after the submission was received.
What is the product code of K110859?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.