The following data is part of a premarket notification filed by Dentack Impants Ltd with the FDA for Quad Dental Implants And Prostheses.
| Device ID | K152188 |
| 510k Number | K152188 |
| Device Name: | QUAD Dental Implants And Prostheses |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Dentack Impants Ltd 24 Ha Ta'as St Kfar-saba, Pob 2405, IL 4464102 |
| Contact | David Salton |
| Correspondent | Tali Hazan TALMED LTD M.P.UPPER GALILEE Ramot Naftali, IL 13830 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-05 |
| Decision Date | 2016-01-28 |
| Summary: | summary |