Device Classification Name |
implant, endosseous, root-form
|
510(k) Number |
K171197 |
Device Name |
Zuga Dental Implant System |
Applicant |
Zuga Medical, Inc. |
24400 Chagrin Blvd, Suite 250 |
Beachwood,
OH
44122
|
|
Applicant Contact |
Chan Wang |
Correspondent |
Zuga Medical, Inc. |
24400 Chagrin Blvd, Suite 250 |
Beachwood,
OH
44122
|
|
Correspondent Contact |
Chan Wang |
Regulation Number | 872.3640
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/24/2017 |
Decision Date | 06/30/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|