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 |