The following data is part of a premarket notification filed by Kettenbach Gmbh & Co Kg with the FDA for Visalys Core, Visalys Pl-core, Visalys Pl-core-c, Visalys Pl-core-x.
| Device ID | K143104 |
| 510k Number | K143104 |
| Device Name: | Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X |
| Classification | Material, Tooth Shade, Resin |
| Applicant | KETTENBACH GMBH & CO KG IM HEERFELD 7 Eschenburg, DE D-35713 |
| Contact | Katja Simon |
| Correspondent | Katja Simon KETTENBACH GMBH & CO KG IM HEERFELD 7 Eschenburg, DE D-35713 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-29 |
| Decision Date | 2015-03-25 |
| Summary: | summary |