The following data is part of a premarket notification filed by Argon Med. Productions Vertriebs Gesellschaft Mbh Co Kg with the FDA for K3pro Konus New Abutments And Implants.
| Device ID | K190192 |
| 510k Number | K190192 |
| Device Name: | K3Pro Konus New Abutments And Implants |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Argon Med. Productions Vertriebs Gesellschaft MBH Co Kg Franz-Kirsten-Str. 1 Bingen Am Rhein, DE 55411 |
| Contact | Richard Donaca |
| Correspondent | Celline Lakus Argon Dental USA, LLC 1000 Corporate Drive Marshfield, WI 54449 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-04 |
| Decision Date | 2020-02-10 |