The following data is part of a premarket notification filed by Biotech Dental, Sas with the FDA for Kontact Dental Implant System.
| Device ID | K210220 |
| 510k Number | K210220 |
| Device Name: | Kontact Dental Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | BIOTECH DENTAL, SAS 305 Allées De Craponne Salon De Provence, FR 13300 |
| Contact | Delphine Mercier |
| Correspondent | Kevin A. Thomas PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-27 |
| Decision Date | 2021-06-18 |