Device Classification Name |
Implant, Endosseous, Root-Form
|
510(k) Number |
K200386 |
Device Name |
Z5-BL |
Applicant |
Z-Systems AG |
Werkhofstrasse 5 |
Oensingen,
CH
CH-4702
|
|
Applicant Contact |
Rubino DiGirolamo |
Correspondent |
PaxMed International, LLC |
12264 El Camino Real, Suite 400 |
San Diego,
CA
92130
|
|
Correspondent Contact |
Kevin A. Thomas |
Regulation Number | 872.3640
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/18/2020 |
Decision Date | 10/14/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|