The following data is part of a premarket notification filed by Alphadent Implants Ltd with the FDA for Alphadent Implants Dental Implants System.
| Device ID | K180968 |
| 510k Number | K180968 |
| Device Name: | AlphaDent Implants Dental Implants System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | AlphaDent Implants Ltd Carl-Zeiss-Str 4 Leonberg-gebershein, DE 71229 |
| Contact | Natalia Kenig |
| Correspondent | Simha Sibony Qualitech Top Ltd. P.O. Box 12082 Nahariya, IL 2201202 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-13 |
| Decision Date | 2019-07-03 |