The following data is part of a premarket notification filed by Alfa Gate Mazen Ltd with the FDA for Alfa Gate Dental Implants System.
| Device ID | K182143 |
| 510k Number | K182143 |
| Device Name: | ALFA GATE Dental Implants System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Alfa Gate Mazen Ltd Hitin St.2, P.O. Box 301 Kfar Qara, IL 3007500 |
| Contact | Mohamad Zahalka |
| Correspondent | Daniela Levy Sterling Medical Registration 22815 Ventura Blvd Woodland Hills, CA 91364 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-07 |
| Decision Date | 2019-10-03 |