The following data is part of a premarket notification filed by Nova Implants Ltd. with the FDA for Nova Dental Implants System.
| Device ID | K150363 |
| 510k Number | K150363 |
| Device Name: | NOVA Dental Implants System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | NOVA Implants Ltd. 5 Yoni Nethanyhu Street Or Yehuda, IL 6037603 |
| Contact | Dan Grimberg |
| Correspondent | Daniela Levy Sterling Medical Registration 22817 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 | 2015-02-12 |
| Decision Date | 2015-06-29 |
| Summary: | summary |