The following data is part of a premarket notification filed by Dentack Implants Ltd with the FDA for Pyramidion Dental Implants And Prostheses.
| Device ID | K180859 |
| 510k Number | K180859 |
| Device Name: | PYRAMIDION Dental Implants And Prostheses |
| Classification | Implant, Endosseous, Root-form |
| Applicant | DenTack Implants Ltd 24 HaTa'as St. POB 2405 Kfar-saba, IL 4464102 |
| Contact | Tali Hazan |
| Correspondent | Tali Hazan DenTack Implants Ltd 24 HaTa'as St. POB 2405 Kfar-saba, IL 4464102 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-02 |
| Decision Date | 2018-12-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290112280763 | K180859 | 000 |
| 07290112280749 | K180859 | 000 |
| 07290112280725 | K180859 | 000 |
| 07290112280701 | K180859 | 000 |
| 07290112280688 | K180859 | 000 |
| 07290112280664 | K180859 | 000 |
| 07290112280329 | K180859 | 000 |