The following data is part of a premarket notification filed by Kettenbach Gmbh & Co. Kg with the FDA for Visalys Restorative Primer.
| Device ID | K191523 |
| 510k Number | K191523 |
| Device Name: | Visalys Restorative Primer |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | Kettenbach GmbH & Co. KG Im Heerfeld 7 Eschenburg, DE 35713 |
| Contact | Katja Simon |
| Correspondent | Katja Simon Kettenbach GmbH & Co. KG Im Heerfeld 7 Eschenburg, DE 35713 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-10 |
| Decision Date | 2019-10-09 |
| Summary: | summary |