Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X
FDA 510(k) K143104 · Kettenbach GmbH & Co. KG
510(k) numberK143104
Submission
- Device name
- Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X
- Applicant
- Kettenbach GmbH & Co. KG
Eschenburg, DE - Received
- October 29, 2014
- Decision date
- March 25, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K262202 | Cerasmart ForteEBF · Traditional | GC America, Inc. | 09/10/2026SE |
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| K261246 | SRGC-06EBF · Traditional | GC America, Inc. | 06/18/2026SE |
| K261093 | DiafilEBF · Traditional | DiaDent Group International | 06/02/2026SE |
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| 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 |
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| K191523 | Visalys Restorative PrimerKLE · Traditional | 10/09/2019SE |
| K191524 | Visalys Tooth PrimerKLE · Traditional | 09/29/2019SE |
| K122039 | Kingscross PL-C+B-10, Kingscross PL-C+B-12, Kingscross PL-C+B-08, Kingscross BEBG · Traditional | 12/27/2012SE |
| K113279 | Identium Heavy, Identium Medium, Identium Scan Heavy, Identium Scan Medium, Identium…ELW · Special | 11/14/2011SE |
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Questions and answers
When was Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X cleared by the FDA?
Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X (K143104) received a 510(k) decision of Substantially Equivalent on March 25, 2015, 147 days after the submission was received.
What is the product code of K143104?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.