The following data is part of a premarket notification filed by Southern Implants (pty) Ltd with the FDA for Deep Conical (dc) Implants And Accessories.
Device ID | K163060 |
510k Number | K163060 |
Device Name: | Deep Conical (DC) Implants And Accessories |
Classification | Implant, Endosseous, Root-form |
Applicant | SOUTHERN IMPLANTS (PTY) LTD 1 ALBERT ROAD Irene, ZA 0062 |
Contact | Lauranda Breytenbach |
Correspondent | Yolanda Smith SMITH ASSOCIATES 1468 HARWELL AVENUE Crofton, MD 21114 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-11-01 |
Decision Date | 2017-06-13 |
Summary: | summary |