Device Classification Name |
Implant, Endosseous, Root-Form
|
510(k) Number |
K182219 |
Device Name |
SGS Dental Implants System |
Applicant |
SGS International Ltd |
Karolyi Istvan Street 1-3 |
Budapest,
HU
H 1047
|
|
Applicant Contact |
Michaeli Shabtai |
Correspondent |
Sterling Medical Registration |
22815 Ventura blvd |
Woodland Hills,
CA
91364
|
|
Correspondent Contact |
Daniela Levy |
Regulation Number | 872.3640
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/15/2018 |
Decision Date | 08/29/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|